Apparatus and methods for maintaining sterility of a specimen container

ABSTRACT

An apparatus includes a fluid reservoir, a sterilization member, and a transfer adapter. The sterilization member operably couples to the fluid reservoir. The sterilization member is configured to be transitioned between a first configuration, in which the sterilization member obstructs an inlet surface of the fluid reservoir and maintains the inlet surface in a substantially sterile environment, and a second configuration, in which the inlet surface is unobstructed. The transfer adapter is configured to be placed in fluid communication with a portion of a patient. The transfer adapter is configured to move relative to the sterilization member from a first position to a second position such that a surface of the transfer adapter contacts the sterilization member to transition the sterilization member to the second configuration. The fluid reservoir is placed in fluid communication with the transfer adapter when the transfer adapter is in the second position.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to and the benefit of U.S. ProvisionalPatent Application Ser. No. 62/213,875 entitled, “Apparatus and Methodsfor Maintaining Sterility of a Specimen Container,” filed Sep. 3, 2015,the disclosure of which is incorporated herein by reference in itsentirety.

BACKGROUND

Embodiments described herein relate generally to the parenteralprocurement of bodily-fluid samples, and more particularly to systemsand methods for parenterally-procuring bodily-fluid samples with reducedcontamination from microbes or other contaminants exterior to thebodily-fluid source that can potentially distort the results ofdiagnostic testing in a healthcare setting.

Health care practitioners routinely perform various types of microbialas well as other broad diagnostic tests on patients usingparenterally-obtained bodily-fluids. As advanced diagnostic technologiesevolve and improve, the speed and value of information that can beprovided to clinicians continues to improve. As such, ensuring that thebodily-fluid sample to be analyzed is collected in a fashion thatmaintains specimen integrity similarly ensures that analyticaldiagnostic results are representative of the in vivo conditions of apatient. Examples of diagnostic technologies that are reliant on highquality, non-contaminated bodily-fluid samples include but are notlimited to microbial detection, molecular diagnostics, geneticsequencing (e.g., DNA, RNA), and the like. When biological matter, cellsexternal to the intended source for sample procurement, and/or otherexternal contaminants are inadvertently included in the bodily-fluidsample that is to be analyzed, the opportunity for an adulteratedspecimen driving a potentially inaccurate patient diagnosis may occur.

In some instances, patient samples (e.g., bodily-fluids) are tested forthe presence of one or more potentially undesirable microbes, such asbacteria, fungi, or yeast (e.g., Candida).

Microbial testing may include incubating patient samples in one or moresterile and/or non-sterile vessels containing culture media or othertypes of solutions that are conducive to microbial growth and/or otherreal-time diagnostic approaches including molecular polymerase chainreaction-based (PCR-based) and/or other technologies (e.g. magneticresonance, automated microscopy, spatial clone isolation, etc.) used torapidly detect and identify organisms. Generally, when microbes testedfor are present in the patient sample, the microbes flourish over timein the culture medium. These organisms may also be identified by otheradvanced diagnostic testing technologies (e.g., molecular diagnostics,PCR, genetic testing/sequencing, magnetic resonance, automatedmicroscopy, spatial clone isolation, etc.). In the case of employing aculture medium, after an amount of time (e.g., a few hours to severaldays—which can be longer or shorter depending on the diagnostictechnology employed), organism growth can be detected by automated,continuous monitoring. For example, in some instances, such automatedmonitoring can detect carbon dioxide produced by organism growth. Thepresence of microbes in the culture medium (as indicated by observationof carbon dioxide) and/or via other detection methods suggests thepresence of the same microbes in the patient sample which, in turn,suggests the presence of the same microbes in the bodily-fluid of thepatient from which the sample was obtained. Accordingly, when microbesare determined to be present in the culture medium (or more generally inthe sample used for testing), the patient may be prescribed one or moreantibiotics or other treatments specifically designed to treat orotherwise remove the undesired microbes from the patient.

Generally, patient bodily-fluid samples are collected in varioussettings and are then transported to a laboratory-type environment forprocessing and analysis. For example, the settings for collecting thepatient sample(s) could include an outpatient clinic, a hospital(including emergency department, intensive care unit (ICU),medical/surgical floor, or the like) or a commercial setting (includinga drugstore or any other commercial enterprise that assists withcollection of bodily-fluid sample(s)). In all settings, typically,protocols are developed, implemented, and monitored to ensure thequality of the collection, handling, preparation, transportation, etc.of a patient's bodily-fluid sample(s). Generally, practitioners attemptto ensure the integrity of the patient specimen(s), understanding thatif the sample is adulterated and/or contains matter that is notrepresentative of the patient's in vivo condition, a diagnostic errorand ensuing inaccurate treatment decision(s) may occur.

In some instances, patient samples, nonetheless, can become contaminatedduring procurement. For example, some equipment used in phlebotomyprocedures can include multiple fluidic interfaces (e.g., patient toneedle, peripheral IV to catheter, needle/tubing to sample vessels,etc.) that can each introduce points of potential contamination.Additionally, the equipment used to procure, transfer, transport, and/orotherwise contain a patient sample are typically connected and/orotherwise placed in fluid communication via manual intervention (e.g., adoctor, phlebotomist, nurse, etc. handles and/or manipulates theequipment). Since the interfaces of the equipment are not consistentlypreassembled and/or sterilized as a single fluidically coupled system,external contaminants (e.g., microbes, dermally-residing organisms,cells from the patient that are not from the intended source ofbodily-fluid to be tested, etc.) can be introduced to the patient samplevia multiple sources (e.g. ambient air, contaminants on surfaces oftables and/or counters in patient room, microbes transferred from linensor clothing, skin deposited on collection supplies from a healthcareworker during assembly and/or sample procurement or transfer, cells fromanother source within the patient, and/or the like). In some instances,the contaminants can lead to a positive microbial and/or otherdiagnostic test result, thereby falsely indicating the presence of suchmicrobes or other cells and/or other biological matter in vivo. Suchinaccurate results are a concern when attempting to diagnose or treat asuspected illness or condition. For example, false positive results frommicrobial tests may result in the patient being unnecessarily subjectedto one or more anti-microbial therapies, which may cause serious sideeffects to the patient including, for example, death, as well as producean unnecessary burden and expense to the healthcare system.

As such, a need exists for improved systems and methods for disinfectionof specimen container(s) that reduce microbial and/or any other types ofcontamination associated with the collection of bodily-fluid testsamples by, for example, disinfecting equipment and/or fluidicinterfaces to ensure the integrity of the patient sample(s) that arecollected and analyzed in diagnostic processes to minimize and/orsubstantially eliminate false positive as well as false negativediagnostic results.

SUMMARY

Apparatus and methods for parenterally-procuring bodily-fluid sampleswith reduced contamination from microbes exterior to the bodily-fluidsource and/or other undesirable external contaminants or biologicalmatter are described herein. In some embodiments, an apparatus includesa fluid reservoir, a sterilization member, and a transfer adapter. Thefluid reservoir has an inlet surface and is configured to receive avolume of bodily-fluid transferred from a patient. The sterilizationmember operably couples to the fluid reservoir and defines at least aportion of a substantially sterile environment. The sterilization memberis configured to be transitioned between a first configuration, in whichthe sterilization member obstructs the inlet surface and maintains theinlet surface in the substantially sterile environment, and a secondconfiguration, in which the inlet surface is unobstructed. The transferadapter is configured to be placed in fluid communication with a portionof a patient. The transfer adapter is configured to move relative to thesterilization member from a first position to a second position. Asurface of the transfer adapter is configured to contact thesterilization member as the transfer adapter moves to the secondposition to transition the sterilization member from the firstconfiguration to the second configuration. The fluid reservoir is placedin fluid communication with the transfer adapter when the transferadapter is in the second position.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic illustration of a bodily-fluid collection deviceaccording to an embodiment.

FIG. 2 is a perspective view of a sample reservoir according to anembodiment.

FIG. 3 is a perspective view of a portion of a bodily-fluid collectiondevice according to an embodiment.

FIG. 4 is a perspective view of a sterilization and/or disinfectionmember, a sample reservoir, and a transfer adapter included in thebodily-fluid collection device of FIG. 3.

FIG. 5 is a perspective view of a portion of a bodily-fluid collectiondevice in a first configuration, according to an embodiment.

FIG. 6 is a perspective view of at least a portion of a transfer adapterincluded in the portion of the bodily-fluid collection device of FIG. 5.

FIG. 7 is a perspective view of a sterilization and/or disinfectionmember included in the portion of the bodily-fluid collection device ofFIG. 5.

FIG. 8 is a perspective view of a portion of the bodily-fluid collectiondevice of FIG. 5.

FIG. 9 is a perspective view of the sterilization and/or disinfectionmember of FIG. 7, in a second configuration.

FIG. 10 is a perspective view of a portion of the bodily-fluidcollection device of FIG. 5, in a second configuration.

FIG. 11 is a perspective view of a portion of a bodily-fluid collectiondevice in a first configuration, according to an embodiment.

FIG. 12 is a partially exploded view of a sterilization and/ordisinfection member and a sample reservoir included in the bodily-fluidcollection device of FIG. 11.

FIGS. 13 and 14 are perspective views of the bodily-fluid collectiondevice of FIG. 11 as the bodily-fluid collection device is transitionedfrom a first configuration to a second configuration.

FIGS. 15-17 are perspective views of a bodily-fluid collection device ina first, a second, and a third configuration, respectively, according toan embodiment.

FIGS. 18-20 are perspective views of a bodily-fluid collection device ina first, a second, and a third configuration, respectively, according toanother embodiment.

FIG. 21 is a perspective view of the bodily-fluid collection device ofFIG. 18 in, for example, in an optional fourth configuration.

FIGS. 22-24 are perspective views of a bodily-fluid collection device ina first, a second, and a third configuration, respectively, according toanother embodiment.

FIG. 25 is a flowchart illustrating a method of parentally-procuringbodily-fluid samples with reduced contamination, according to anembodiment.

DETAILED DESCRIPTION

In some embodiments, an apparatus includes a fluid reservoir, asterilization member, and a transfer adapter. The fluid reservoir has aninlet surface and is configured to receive a volume of bodily-fluidtransferred from a patient. The sterilization member operably couples tothe fluid reservoir and defines at least a portion of a substantiallysterile environment. The sterilization member is configured to betransitioned between a first configuration, in which the sterilizationmember obstructs the inlet surface and maintains the inlet surface inthe substantially sterile environment, and a second configuration, inwhich the inlet surface is unobstructed. The transfer adapter isconfigured to be placed in fluid communication with a portion of apatient. The transfer adapter is configured to move relative to thesterilization member from a first position to a second position. Asurface of the transfer adapter is configured to contact thesterilization member as the transfer adapter moves to the secondposition to transition the sterilization member from the firstconfiguration to the second configuration. The fluid reservoir is placedin fluid communication with the transfer adapter when the transferadapter is in the second position.

In some embodiments, a system for parenterally-procuring bodily-fluidsamples with reduced contamination from microbes exterior to thebodily-fluid source includes a sample reservoir, a handle, and anadapter. The handle is configured to be placed in fluid communicationwith a patient. The handle has a coupler, a fluid reservoir, and anactuator. The fluid reservoir is disposed within the handle andconfigured to receive a volume of bodily-fluid from the patient. Theactuator is configured to be transitioned between a first configuration,in which the coupler is fluidically isolated from the fluid reservoir,and a second configuration, in which the coupler is in fluidcommunication with the fluid reservoir. The adapter is configured to becoupled to the coupler of the handle. The adapter is at leasttemporarily coupled to a sterilization member and to the samplereservoir such that an inlet surface of the sample reservoir ismaintained in a substantially sterile environment collectively definedby the adapter and the sterilization member prior to the adapter beingcoupled to the coupler of the handle. The sterilization member is atleast partially removed from the adapter when the adapter is coupled tothe coupler of the handle.

In some embodiments, a method for parenterally-procuring bodily-fluidsamples with reduced contamination from microbes exterior to thebodily-fluid source includes establishing fluid communication between apatient and a first fluid reservoir, which in turn, is in selectivefluid communication with a transfer adapter. A volume of bodily-fluid iswithdrawn from the patient and into the first fluid reservoir. A secondfluid reservoir is coupled to the to the transfer adapter. The secondfluid reservoir has an inlet surface and is coupled to a sterilizationmember configured to at least temporarily obstruct the inlet surface.The sterilization member is moved relative to the inlet surface suchthat the inlet surface is unobstructed by the sterilization member asthe second fluid reservoir is coupled to the transfer adapter. Thesecond fluid reservoir is placed in fluid communication with thetransfer adapter when the portion of the second fluid reservoir iscoupled to the transfer adapter and the inlet surface is unobstructed bythe sterilization member. Fluid communication between the first fluidreservoir and the second fluid reservoir is established and a volume ofbodily-fluid is transferred from the first fluid reservoir to the secondfluid reservoir.

In some embodiments, an apparatus includes a sterilization and/ordisinfection member at least temporarily coupled to a sample reservoir.The sample reservoir includes an inlet port that is configured to befluidically coupled to a transfer device to receive a volume ofbodily-fluid directly from a patient or indirectly from the patient viaan intermediary bodily-fluid collection device. The sterilization and/ordisinfection member is configured to be placed in contact with thetransfer device and transitioned from a first configuration, in whichthe sterilization and/or disinfection member fluidically isolates theinlet port of the fluid reservoir, to a second configuration, in whichat least a portion of the sterilization and/or disinfection member isspaced apart from the sample reservoir. The sample reservoir isconfigured to be placed in fluid communication with the transfer devicevia the inlet port when the sterilization and/or disinfection member isin the second configuration.

In some embodiments, a sterilization and/or disinfection member iscoupled to a sample reservoir during a manufacturing process in aposition that prevents the clinician from collecting and/or transferringa bodily-fluid sample into a fluid reservoir(s) without engaging thesterilization and/or disinfection member to at least substantiallysterilize a connection therebetween, which in turn, facilitates fluidcommunication of a bodily-fluid sample between the patient and thecollection vessel. By ensuring that substantially no externalcontaminants and/or biological matter (e.g., skin cells, tumor cells,organ tissue, etc.) external to the target bodily-fluid source arecaptured in the sample vessel, diagnostic results can improve withincreased consistency. With accurate diagnostic results, clinicians canderive an accurate treatment/action plan, thereby reducing thelikelihood of misdiagnosing a patient, prescribing unnecessarytreatment, holding the patient in a clinical and/or hospital setting foran undue and/or unnecessary period of time, and/or the like, which inturn, can substantially reduce a risk of the patient developing afurther ailment (e.g., antibiotic complications, adverse drug reactions,hospital-acquired infection, and/or the like) as well as substantiallyreduce costs to hospital and/or other healthcare institutions, thirdparty payers and the healthcare systems as a whole.

As used in this specification, the singular forms “a,” “an” and “the”include plural referents unless the context clearly dictates otherwise.Thus, for example, the term “a member” is intended to mean a singlemember or a combination of members, “a material” is intended to mean oneor more materials, or a combination thereof.

As referred to herein, “bodily-fluid” can include any fluid obtainedfrom a body of a patient, including, but not limited to, blood,cerebrospinal fluid, urine, bile, lymph, saliva, synovial fluid, serousfluid, pleural fluid, amniotic fluid, and the like, or any combinationthereof.

As used herein, the term “set” can refer to multiple features or asingular feature with multiple parts. For example, when referring to setof walls, the set of walls can be considered as one wall with distinctportions, or the set of walls can be considered as multiple walls.Similarly stated, a monolithically constructed item can include a set ofwalls. Such a set of walls can include, for example, multiple portionsthat are in discontinuous from each other. A set of walls can also befabricated from multiple items that are produced separately and arelater joined together (e.g., via a weld, an adhesive or any suitablemethod).

As used herein, the words “proximal” and “distal” refer to the directioncloser to and away from, respectively, a user who would place the deviceinto contact with a patient. Thus, for example, the end of a devicefirst touching the body of the patient would be the distal end, whilethe opposite end of the device (e.g., the end of the device beingmanipulated by the user) would be the proximal end of the device.

As used herein, the term “disinfecting agent” refers to a chemical orcombination of chemicals used to disinfect and/or to substantiallysterilize or maintain the sterility of a surface. A disinfecting agentcan be in any suitable form (e.g., gaseous, aqueous, or solid). In someembodiments, a disinfecting agent can be an antiseptic or the like thatcan be used to kill, destroy, and/or otherwise substantially neutralizenegative effects from microbes such as, for example, germs, bacteria,viruses, and/or other target microorganisms. In some embodiments, adisinfecting agent can be in an aqueous form and substantially suspendedby a porous substrate. In other embodiments, a surface of a substratesuch as a wipe or diaphragm can be impregnated by and/or coated with adisinfecting agent. A non-limiting list of disinfecting agents caninclude, for example, alcohol (e.g., ethanol, 1-propanol, 2-proponal,isopropanol, and/or the like), quaternary ammonium compounds ((e.g.,benzalkonium chloride (BAC), cetyl trimethylammonium bromide (CTMB),cetylpyridinium chloride (Cetrim (CPC)), benzethonium chloride (BZT)and/or the like), boric acid, chlorhexidine gluconate, hydrogenperoxide, iodine, octenidine dihydrochloride, phenol, polyhexanide(e.g., polyhexamethylene biguanide (PHMB)), sodium bicarbonate, silvercompounds (e.g., silver nitrate, silver proteinate,chlorhexidine-silver-sulfadiazine, and/or the like), and/or any othersuitable disinfectant or antiseptic, and/or a combination thereof.Moreover, any of the disinfecting agents can be used with, for example,a binding agent, a suspension agent, a surfactant, and/or the like.

FIG. 1 is a schematic illustration of a bodily-fluid collection device100, according to an embodiment. Generally, the bodily-fluid collectiondevice 100 (also referred to herein as “collection device”) isconfigured to disinfect and/or otherwise maintain the sterility of oneor more interfaces prior to defining a fluidic coupling to reduceexternal contaminants residing on the interfaces. Once disinfected, theone or more interfaces can be fluidically coupled to allow a flow ofbodily-fluid that is substantially free of external contaminants to flowfrom a patient to a fluid reservoir either directly or via anintermediary device.

The collection device 100 includes a transfer adapter 120, a fluidreservoir 140, and a sterilization and/or disinfection member 150. Thetransfer adapter 120 has a proximal end portion 121 and a distal endportion 122, and defines an inner volume 130 therebetween. The transferadapter 120 can be any suitable shape, size, or configuration. Forexample, the transfer adapter 120 can be substantially cylindrical,including a set of annular walls that define at least a portion of theinner volume 130. In other embodiments, the transfer adapter 120 can bepolygonal such as rectangular, pentagonal, octagonal, etc. Moreover, asshown in FIG. 1, the transfer adapter 120 (and/or a set of walls of thetransfer adapter 120) can house and/or receive at least a portion of thefluid reservoir 140 and the sterilization and/or disinfection member150. Although not shown in FIG. 1, in some embodiments, the transferadapter 120 can include and/or can be coupled to a puncture member,port, and/or any other suitable transfer device configured tofluidically couple the transfer adapter 120 to an inner volume (notshown) of the fluid reservoir 140 (e.g., a needle that can puncture aport, septum, or portion of the fluid reservoir 140).

The proximal end portion 121 of the transfer adapter 120 can besubstantially open to movably receive at least a portion of the fluidreservoir 140. In other words, at least a portion of the fluid reservoir140 can be inserted through the proximal end portion 121 of the transferadapter 120 to dispose that portion of the fluid reservoir 140 withinthe inner volume 130. As described in further detail herein, once theportion of the fluid reservoir 140 is disposed within the inner volume130 of the transfer adapter 120, the fluid reservoir 140 can be movedfrom a first position in which the sterilization and/or disinfectionmember 150 obstructs, covers, engages, disinfects, and/or otherwisesubstantially maintains the sterility of a port of the fluid reservoir140 to a second position in which the sterilization and/or disinfectionmember 150 is at least partially disengaged from the fluid reservoir 140to allow access to the port.

Although not shown in FIG. 1, the distal end portion 122 of the transferadapter 120 can be physically and fluidically coupled to any suitablelumen-defining device (e.g., as a catheter, cannula, needle, trocar, orthe like), collection device, transfer device, diversion device, and/orthe like. For example, in some embodiments, the distal end portion 122of the transfer adapter 120 can include a port such as a Luer Lok® thatcan be physically and fluidically coupled to a device configured toreceive a flow of bodily-fluids from a patient.

In some embodiments, the transfer adapter 120 can be physically andfluidically coupled to a transfer device that includes and/or is coupledto a peripheral intravenous (IV) needle or a peripheral IV catheter,which places the transfer device in fluid communication with a portionof the patient. In other embodiments, the transfer adapter 120 can beplaced in fluid communication with any suitable intermediary device,which contains and/or receives a bodily-fluid collected from a patientin a separate and/or independent step. In some embodiments, theintermediary device can be a collection device, a diversion device, asyringe-based collection device and/or the like such as those describedin U.S. Pat. No. 8,535,241 entitled, “Fluid Diversion Mechanism forBodily-Fluid Sampling,” filed Sep. 17, 2013 (the “‘241 patent”); U.S.Pat. No. 9,060,724 entitled, “Fluid Diversion Mechanism for Bodily-FluidSampling,” filed May 29, 2013 (the “‘724 patent”); U.S. Pat. No.9,204,864 entitled, “Fluid Diversion Mechanism for Bodily-FluidSampling,” filed Jul. 29, 2013 (the “‘864 patent”); U.S. PatentPublication No. 2014/0155782 entitled, “Sterile Bodily-Fluid CollectionDevice and Methods,” filed Dec. 4, 2013 (the “‘782 publication”); and/orU.S. Pat. No. 9,155,495 entitled, “Syringe-Based Fluid DiversionMechanism for Bodily-Fluid Sampling,” filed Dec. 2, 2013 (the “‘495patent”), the disclosures of which are incorporated herein by referencein their entireties. In addition, the transfer adapter 120 can include apuncture member or the like (as described above) in fluid communicationwith such a transfer device, which in turn, can puncture a portion,surface, and/or port of the fluid reservoir 140 to establish fluid flowpath between the patient and the fluid reservoir 140. Although describedas being physically and fluidically coupled to a transfer device, inother embodiments, the transfer adapter 120 can be monolithically formedwith a transfer device. In still other embodiments, the transfer adapter120 can be operably coupled to a transfer device via any suitableintervening structure (e.g., via sterile flexible tubing, one or morecannulas, one or more intermediate devices, one or more fluidreservoirs, and/or the like).

Although not shown in FIG. 1, the transfer adapter 120 can include oneor more seals and/or disinfection members removably coupled to a surfaceof the transfer adapter 120, which, prior to use, can fluidicallyisolate the inner volume 130 from a volume outside of the transferadapter 120. For example, in some embodiments, the proximal end portion121 of the transfer adapter 120 can include a seal and/or disinfectionmember that can be removably coupled to a proximal surface of thetransfer adapter 120 to substantially cover an opening defined by theproximal end portion 121. Such a seal can be, for example, a housing, acap, a relatively thin sheet or film, Tyvek® material, an elastomericmember (e.g., a plunger or stopper), and/or the like. As such, the sealcan fluidically isolate the inner volume 130 to substantially maintainthe sterility of the inner volume 130 prior to use. In some embodiments,the transfer adapter 120 can include any of the seals and/ordisinfection members described in U.S. Patent Publication No.2015/0246352 entitled, “Apparatus and Methods for Disinfection of aSpecimen Container,” filed Mar. 3, 2015, the disclosure of which isincorporated herein by reference in its entirety.

As described above, the fluid reservoir 140 is configured to be placedin fluid communication with the transfer adapter 120 to, for example,receive a volume of bodily-fluid from a patient. In some embodiments,the fluid reservoir 140 includes a surface 141 that can be pierced,punctured, and/or otherwise placed in an open configuration to place aninner volume of the fluid reservoir 140 in fluid communication with avolume outside of the fluid reservoir 140. For example, in someembodiments, the surface 141 can include and/or can define a frangibleportion, a port, a septum, and/or the like that can be pierced, forexample, by a puncture member included in the transfer adapter 120 toplace the inner volume of the fluid reservoir 140 in fluid communicationwith transfer adapter 120 and any suitable device coupled thereto, asdescribed in further detail herein.

The fluid reservoir 140 can be any suitable shape, size, and/orconfiguration that can receive and/or store a volume of a bodily-fluid.For example, in some embodiments, the fluid reservoir 140 can be anysuitable reservoir described in U.S. Pat. No. 8,197,420 (“the ‘420patent”), entitled, “Systems and Methods for Parenterally ProcuringBodily-Fluid Samples with Reduced Contamination,” filed on Dec. 13,2007, the disclosure of which is incorporated herein by reference in itsentirety. In some embodiments, the fluid reservoir 140 can define anegative pressure and/or otherwise can be substantially evacuated. Forexample, in some embodiments, the fluid reservoir 140 can be aBacT/ALERT® SN or a BacT/ALERT® FA (manufactured by BIOMERIEUX, INC.), aBD Vacutainer® or a BD Microtainer® (manufactured Becton, Dickinson, andCompany (BD)), a Nanotainer™ (manufactured by Theranos), and/or anysuitable reservoir, syringe, vial, microvial, microliter vial,container, microcontainer, or the like.

In some embodiments, the fluid reservoir 140 can be any suitable sampleor culture bottle such as, for example, an aerobic or anaerobic culturebottle containing a culture medium. In such embodiments, a bodily-fluidsample volume can be delivered and/or transferred into the a culturebottle (e.g., the fluid reservoir 140) and after a given time,incubation period, or the like, microbes contained in the bodily-fluidsample can flourish or grow within the culture medium. After theincubation period, the bodily-fluid sample can be tested to determinequantitative and/or qualitative information associated with suchmicrobial growth within the culture medium. In some instances, forexample, the bodily-fluid samples can be tested via real-timediagnostics including molecular PCR-based technologies, genetictesting/diagnostics, and/or any other suitable test. In some instances,results of such testing can be indicative of the presence ofGram-Positive bacteria, Gram-Negative bacteria, fungi, yeast (e.g.,Candida), and/or any other contaminants or organisms contained withinthe bodily-fluid sample, which in turn, is indicative of their presencewithin the patient. As described above, however, contaminants ormicrobes external to the body of the patient that are transferred intothe inner volume of fluid reservoir 140 and/or otherwise entrained inthe flow of the bodily-fluid sample can result in false positive orfalse negative results when testing bodily-fluid sample. Thus, disposingthe sterilization and/or disinfection member 150 about a fluidicinterface of the fluid reservoir 140 (e.g., at least a portion of thesurface 141) prior to use can reduce a likelihood of such contaminantsbeing transferred into the fluid reservoir 140, as described in furtherdetail herein.

The sterilization and/or disinfection member 150 can be any suitablesterilization and/or disinfection member and/or mechanism that is atleast temporarily coupled to a portion of the fluid reservoir 140 to atleast temporarily maintain a sterility of the portion of the fluidreservoir 140. In some embodiments, the sterilization and/ordisinfection member 150 can disinfect the portion of the fluid reservoir140 to remove contaminants and/or the like. The sterilization and/ordisinfection member 150 (also referred to herein as “sterilizationmember”) can be, for example, a pad, a swab, a diaphragm, a sponge, awipe, a cap, a foil, and/or the like that can include and/or the can atleast partially house a disinfecting agent. In some embodiments, thesterilization member 150 can be a diaphragm or the like that can have atleast one surface that is substantially impregnated with a disinfectingagent such as those described above. In some embodiments, thesterilization member 150 can include and/or can define a portion that issubstantially porous, for example, to act as a substrate for thedisinfection agent. In other embodiments, the sterilization member 150can include a surface that is formed from a disinfecting material suchas, for example, a silver compound.

In some embodiments, the sterilization member 150 can be a sheet, foil,cap, membrane, diaphragm, and/or the like that can form a substantiallyfluid tight seal with a portion of the fluid reservoir 140. For example,the sterilization member 150 can be coupled to, in contact with, and/orotherwise disposed about at least a portion of the surface 141 of thefluid reservoir 140 such that at least the portion of the surface 141 ismaintained in a substantially sterile environment prior to use. Forexample, in some embodiments, such a sterilization member 150 can becoupled to the fluid reservoir 140 during a manufacturing processperformed in a substantially sterile environment. In some embodiments, adisinfecting agent can be disposed within the volume at least partiallycircumscribed by a seal formed by the sterilization member 150 (e.g.,ethylene oxide gas, gamma radiation or the like can be used to create asterile environment within the inner volume).

In use, a user (e.g., a doctor, nurse, technician, physician,phlebotomist, etc.) can manipulate the collection device 100 to at leastindirectly couple the transfer adapter 120 to a lumen-defining device,transfer device, collection device, diversion device, etc. such as, forexample, a standard winged butterfly needle, a syringe, a peripheral IVcatheter, and/or the like. In some embodiments, such a device can be anyof those described in the ‘241 patent, the ‘724 patent, the ‘348publication, the ‘782 publication, and/or the ‘419 publication. In someinstances, such a device can be placed in communication with a patientprior to being coupled to the transfer adapter 120. In other instances,the transfer adapter 120 can be coupled to, for example, a needle orcannula prior to being inserted (e.g., percutaneously) into the patient.With the transfer adapter 120 in fluid communication with the patient,the user can manipulate the collection device 100 to insert at least aportion of the fluid reservoir 140 into the proximal end portion 121 ofthe transfer adapter 120. In some embodiments, prior to inserting thefluid reservoir 140, the user can manipulate the collection device 100to remove, for example, a seal that substantially covers the proximalend 121 of the transfer adapter 120, as described above.

The user can move the fluid reservoir 140 relative to the transferadapter 120 to place the fluid reservoir 140 in a first position withinthe inner volume 130, thereby placing the collection device 100 in afirst configuration. In some instances, the sterilization member 150 canbe placed in contact with a portion of the transfer adapter 120 such asan inner surface and/or any suitable feature extending from the innersurface when the collection device 100 is in the first configuration.For example, as described above, in some embodiments, the inner surfaceof the transfer adapter 120 can include a surface feature, contour,protrusion, slot, cutting member, peeling member, and/or the likeconfigured to engage the sterilization member 150 as the fluid reservoir140 is inserted and/or moved within the inner volume 130 of the transferadapter 120. In some instances, the user can maintain the fluidreservoir 140 in the first position for a predetermined time (which insome embodiments, is facilitated by physical design characteristics thatprevent the user from bypassing the first position) to ensure thesterilization member 150 is engaged with and/or otherwise in contactwith a desired portion of the transfer adapter 120 prior to moving thefluid reservoir 140 from the first position to a second position withinthe transfer adapter 120. In other embodiments, the fluid reservoir 140need not be held in the first position for the predetermined time. Thatis to say, in some embodiments, the user can move the fluid reservoir140 relative to the transfer adapter 120 (or vice versa) in asubstantially continuous manner to move the fluid reservoir 140 throughthe first position and into the second position.

Once the fluid reservoir 140 has been placed at or near a desiredposition within the transfer adapter 120, a portion of the surface 141(e.g., a portion including a port, septum, seal, etc.) can be exposedand/or otherwise unobstructed by the sterilization member 150. In otherwords, placing the fluid reservoir 140 in a desired position within thetransfer adapter 120 can transition the sterilization member 150 from afirst configuration, in which the sterilization member 150 engages thesurface 141 to substantially maintain the sterility of at least aportion of the surface 141, to a second configuration, in which at leasta portion of the sterilization member 150 is disengaged from the surface141. Specifically, the transfer adapter 120 can remove at least aportion of the sterilization member 150 from contact with the surface141 as the fluid reservoir 140 is placed in the second position, asindicated by the arrow AA in FIG. 1.

With the sterilization member 150 in, for example, the secondconfiguration, a user can then manipulate the transfer adapter 120and/or the fluid reservoir 140 to place the fluid reservoir 140 in fluidcommunication with the transfer adapter 120, as described in detailabove. Thus, the collection device 100 can be used to maintain thesterility of a fluidic interface associated with the surface 141 of thefluid reservoir 140 to reduce the likelihood of contamination frommicrobes disposed on the surface 141. By having the sterilization member150 coupled to the fluid reservoir 140 prior to use, contamination of asample of bodily-fluid can be reduced that might otherwise result frominsufficient disinfection by a user. In addition, having the transferadapter 120 automatically remove the sterilization member 150 as thefluid reservoir 140 is moved relative to the transfer adapter 120 canensure compliance with a substantially consistent sterilization and/ordisinfection process, which in turn, can reduce inaccurate test results,costs, and time associated with collecting and testing a sample volume.

In some embodiments, the collection device 100 and/or the transferadapter 120 can be included in and/or can form at least a portion of apreassembled and/or all-in-one collection device. In such embodiments,the preassembled and/or all-in-one collection device can include, forexample, any suitable number of fluid reservoirs (e.g., one fluidreservoir, two fluid reservoirs, three fluid reservoirs, four fluidreservoirs, or more) that can be preassembled with and/or incorporatedin (e.g., unitarily formed with) a transfer device including asterilization and/or disinfection member such as those described herein.By way of example, in some embodiments, the collection device 100(and/or any suitable portion thereof) can be included in and/or canotherwise form a portion of a preassembled and/or all-in-one collectiondevice such as those described in ‘782 publication incorporated byreference above.

While described above as maintaining at least a portion of the surface141 of the fluid reservoir 140 in a substantially sterile environment,in some embodiments, the sterilization member 150 can be configured todisinfect the surface 141 of the fluid reservoir 140. That is to say,the sterilization member 150 can be used to remove contaminants from thesurface 141 of the fluid reservoir 140 (i.e., to disinfect the surface141 of the fluid reservoir 140). The sterilization and/or disinfectionmembers described herein, therefore, are not intended to be limited toeither function and, for simplicity, are referred to henceforth as“sterilization members.”

Referring to FIG. 2, a fluid reservoir 240 or sample container isillustrated according to an embodiment. In some instances, the fluidreservoir 240 can be used and/or included in, for example, thecollection device 100 described above. Thus, while not shown in FIG. 2,the fluid reservoir 240 can be coupled to and/or can include asterilization member configured, for example, to maintain a sterility ofa portion of the fluid reservoir 240 (e.g., a proximal surface) prior touse. Moreover, the fluid reservoir 240 can be positioned within and/orcan engage a transfer adapter (e.g., such as the transfer adapter 120)and can be moved relative thereto to 1) automatically disengage at leasta portion of the sterilization member, for example, from the proximalsurface and 2) place the fluid reservoir 240 in fluid communication withthe transfer adapter, as described in further detail herein with respectto specific embodiments.

The fluid reservoir 240 can be any suitable reservoir for containing abodily-fluid, including, for example, a single use disposable collectionreservoir, a vacuum based collection reservoir (e.g., maintainingnegative pressure conditions that can produce a suction or vacuumforce), a sample reservoir as described in the ‘420 patent, and/or thelike. While shown as having a bottle shape or the like, the fluidreservoir 240 can be any suitable bottle, tube, vial, microvial,container, syringe, etc. In some embodiments, the reservoir 240 can bean aerobic culture bottle or an anaerobic culture bottles. That is tosay, the fluid reservoir 240 can include an aerobic or anaerobic culturemedium disposed within an inner volume defined by the fluid reservoir240, as described in detail above with reference to the fluid reservoir140. Moreover, the culture medium disposed therein can be associatedwith one or more tests, procedures, and/or actions configured to, forexample, detect the presence of certain microbes that are known tothrive in that medium. In other embodiments, the fluid reservoir 240 caninclude common additives such as heparin, citrate,ethylenediaminetetraacetic acid (EDTA), oxalate, and/or the like thatare used to preserve specific characteristics and/or qualities of abodily-fluid sample (e.g., blood) prior to diagnostic analysis.

In the embodiment shown in FIG. 2, the fluid reservoir 240 includes aproximal surface 241, a proximal rim 243, and a label 242. The proximalsurface 241 can include and/or can otherwise form a port, septum,frangible portion or the like, which can be transitioned from asubstantially sealed configuration to a substantially unsealedconfiguration to place an inner volume of the fluid reservoir in fluidcommunication with a volume outside of the fluid reservoir 240, asdescribed in detail above. In other words, the proximal surface 241 canbe, for example, an inlet surface. The proximal rim 243 can be, forexample, a flange, a rib, a rolled portion, and/or the like. Althoughnot shown in FIG. 2, the proximal rim 243 of the fluid reservoir 240 canbe removably coupled to a sterilization member such as those describedherein. In some embodiments, such a sterilization member, for example,can be coupled to the proximal rim 243 during a manufacturing process orthe like such that at least a portion of the proximal surface 241 ismaintained in a substantially sterile environment prior to use, asdescribed in further detail herein.

As shown in FIG. 2, the label 242 is disposed about a portion of thefluid reservoir 240. The label 242 can be and/or can include a tag orindicia associated with one or more characteristics of the fluidreservoir 240. For example, the label 242 can include a code portionsuch as, for example, a serial number, bar code, a quick response (QR)code, a radio-frequency identification (RFID) tag, a near fieldcommunication (NFC) tag, and/or the like. In this manner, the codeportion can provide a user (e.g., a doctor, phlebotomist, nurse,technician, etc.) with information associated with the fluid reservoir240 such as, for example, the type of culture medium or additive (asdescribed above) disposed therein, the amount (e.g., volume, mass,density, etc.) of the culture medium or additive (as described above)disposed therein, a volume of bodily-fluid that the fluid reservoir 240should receive, a tolerance value, the type of tests to be performed onthe bodily-fluid sample disposed therein, temperature, and/or the like.Thus, the user can determine, inter alia, the amount or the volume ofbodily-fluid that he or she should transfer into the fluid reservoir240.

In some embodiments, the label 242 can include a volumetric indicatorportion or the like that can provide a visual indicator associated withthe bodily-fluid disposed in the fluid reservoir 240. For example, thevolumetric indicator portion can include a set of evenly spaced lines,tic marks, dashes, arrows, markers, and/or any other suitable gradationor indicia that can be associated with a specific volume of the fluidreservoir 240 if filled to that point. In some embodiments, the fluidreservoir 240 can be substantially transparent, allowing the user tovisualize the sample disposed therein. For example, a user can visuallyassess the volume of the bodily-fluid disposed in the fluid reservoir240 by determining at what point along the indicator portion themeniscus of the bodily-fluid aligns. In some embodiments, a device canbe coupled to the fluid reservoir 240 that is configured to verifyand/or otherwise indicate a volume of bodily-fluid transferred into thefluid reservoir such as, for example, those described in U.S. patentapplication Ser. No. 15/146,967 entitled, “Devices and Methods forVerifying a Sample Volume,” filed May 5, 2016, the disclosure of whichis incorporated herein by reference in its entirety. In some suchembodiments, verifying and/or otherwise indicating a volume ofbodily-fluid transferred into the fluid reservoir (e.g., the fluidreservoir 240) can facilitate the transfer of a desired and/orpredetermined volume of the bodily-fluid into the fluid reservoir, whichin turn, can limit false test results otherwise associated with anundesirable volume of the bodily-fluid (e.g., too much bodily-fluid ortoo little bodily-fluid for a given test or tests).

Although the fluid reservoir 240 is specifically described above, inother embodiments, the fluid reservoir 240 can be any suitable shape,size, and/or configuration. For example, while the fluid reservoir 240is shown and described as including the label 242 configured to providea user with information associated with the fluid reservoir 240, inother embodiments, a fluid reservoir without a label and/or otheridentifying portion can be used.

As described above, in some embodiments, the fluid reservoir 240 can becoupled to and/or can include a sterilization member that can be atleast partially disengaged from the fluid reservoir 240 when the fluidreservoir 240 is positioned within a transfer adapter or device. Forexample, FIGS. 3 and 4 illustrate at least a portion of a collectiondevice 300 according to an embodiment. The collection device 300 (orportion thereof) includes a transfer adapter 320 configured to receive aportion of at least one fluid reservoir 340 and at least onesterilization member 350. More specifically, at least a portion of theone or more fluid reservoirs 340 can be inserted into the transferadapter 320, which can be operable to transition the at least onesterilization members 350 from a first configuration, in which the oneor more sterilization members 350 substantially maintain the sterilityof a portion of the one or more fluid reservoirs 340, to a secondconfiguration in which the one or more sterilization members 350 are atleast partially disengaged from the one or more fluid reservoirs 340 toallow the fluid reservoirs 340 to be placed in fluid communication withthe transfer adapter 320, as described in further detail herein.

The collection device 300 (or portion thereof) as shown in FIG. 3,includes a reservoir housing 345 that contains, houses, and/or otherwisereceives two fluid reservoirs 340 (e.g., a first fluid reservoir 340 anda second fluid reservoir 340). In other embodiments, any number of fluidreservoirs 340 can be contained within the housing 345. The fluidreservoirs 340 can be any suitable shape, size, and/or configuration.For example, in some embodiments, the fluid reservoirs 340 aresubstantially similar to and/or the same as the fluid reservoir 240described above with reference to FIG. 2. Thus, the fluid reservoirs 340are not described in further detail herein.

The housing 345 can be any suitable shape, size, and/or configuration.For example, in some embodiments, the housing 345 can have a size and/orshape that is associated with a size and/or shape of the fluid reservoirto be disposed therein. More particularly, the housing 345 defines aninner volume that is sufficient to receive at least the first and secondfluid reservoir 340. As shown in FIG. 3, the housing 345 is coupled tothe sterilization member 350, which is configured to at leasttemporarily fluidically isolate the inner volume of the housing 345 froma volume outside of the housing 345. For example, the housing 345 can bean enclosure that defines one or more openings defined by a sidewall orthe like through which the fluid reservoirs 340 are inserted to bedisposed within the inner volume. As shown, the sterilization member 350is coupled to the sidewall defining the opening to at least temporarilyseal the inner volume of the housing 345. For example, the sterilizationmember 350 can be coupled to and/or in contact with a surface of thesidewall such that the surface of the sidewall and the sterilizationmember 350 collectively define a fluid tight seal. In some embodiments,for example, the sterilization member 350 can be coupled to the surfacevia an adhesive, a standard medical sealing process using, for example,Tyvek, ultrasonic weld, or the like. In this manner, the inner volume ofthe housing 345 is substantially fluidically isolated from a volumeoutside of the housing 345.

In some embodiments, the fluid reservoirs 340 can be disposed in thehousing 345 and the sterilization member 350 can be coupled to thehousing 345 during manufacturing. In such embodiments, for example, thehousing 345 can be substantially sterilized using standard medicalsterilization practices (e.g. ethylene oxide, gamma radiation, e-beam,and/or the like) to facilitate maintenance of a sterile environment.Similarly, the fluid reservoirs 340 can be substantially sterilized anddisposed in the inner volume of the housing 345 while the housing 345and the fluid reservoirs 340 are in the sterile environment. Likewise,the sterilization member 350 can be substantially sterilized and coupledto the housing 345, after the fluid reservoirs 340 have been disposedtherein, while the housing 345, the fluid reservoirs 340, and thesterilization member 350 are disposed in the sterile environment. Thus,while the sterilization member 350 is coupled to the housing 345 and inan unused configuration, the inner volume of the housing 345 (containingthe fluid reservoirs 340) is a substantially sterile volume and/orenvironment. For example, in some embodiments, housing 345, fluidreservoirs 340, sterilization member 350 can be assembled (as describedabove) in a sterile environment such as ethylene oxide gas or the like.Moreover, by sealing the housing 345 with the sterilization member 350,the fluid reservoirs 340 within the inner volume of the housing 345 aremaintained in, for example, an ethylene oxide gas environment until thehousing 345 is unsealed.

The sterilization member 350 can be any shape, size, and/orconfiguration suitable for coupling to the housing 345. For example, thesterilization member 350 can be one or more films, foils, sheets,membranes, diaphragms, and/or the like. More particularly, thesterilization member 350 can include a first portion 356 that isremovably coupled to a second portion 357. The first portion 356 can be,for example, a base configured to be coupled to the housing 345. Assuch, the first portion 356 can be formed from a relatively stiffmaterial that can provide structural integrity for the sterilizationmember 350 to be coupled to the housing 345. The second portion 357 canbe removably coupled to the first portion 356 and can be formed from arelatively flexible material to allow the second portion 357 to deform,bend, fold, peel, and/or otherwise at least partially disengage from thefirst portion 356. Furthermore, a surface of the sterilization member350 (e.g., of the first portion 356) in contact with the surface of thehousing 345 can have and/or can define an area that is greater than anarea defined by the surface of the housing 345. In other words, thesterilization member 350 can form a flange or the like that extendsbeyond a perimeter of the housing 345, as shown in FIG. 3 and asdescribed in further detail herein.

Prior to use, the arrangement of the sterilization member 350 is suchthat the second portion 357 is coupled to the first portion 356 to forma substantially fluid tight seal and/or interface. In some embodiments,for example, a perimeter of the second portion 357 (or an area near aperimeter) can be coupled to an associated perimeter of the firstportion 356 via an adhesive or ultrasonic weld. In other embodiments,substantially the entirety of a surface of the second portion 357 can beadhered to substantially the entirety of a surface of the first portion356. In still other embodiments, the second portion 357 can be coupledto the first portion 356 in any suitable manner. Moreover, the secondportion 357 is coupled to the first portion 356 in such a manner thatthe first portion 356 and the second portion 357 collectively form asubstantially sterile area. For example, in some embodiments, asubstantially sterile area can be circumscribed by a seal defined by thecoupling of the second portion 357 to the first portion 356. In someembodiments, the second portion 357 can be coupled to the first portion356 via an adhesive, which in turn, is impregnated with and/or otherwiseincludes a sterilizing agent such as those described above. Thus, thesterility of an area of the first portion 356 of the sterilizationmember 350 aligned with and/or covering, for example, the opening of thehousing 345 is maintained prior to use.

The transfer adapter 320 can be any suitable transfer adapter. Forexample, in some embodiments, the transfer adapter 320 can besubstantially similar to the transfer adapter 120 described above withreference to FIG. 1. Thus, aspects of the transfer adapter 320 are notdescribed in further detail herein. As shown in FIG. 4, the transferadapter 320 includes an inner surface 323 that defines an inner volume330 configured to receive a portion of the housing 345 and at least aportion of the sterilization member 350. Although not shown in FIG. 4,the transfer adapter 320 can include a puncture member, a port, atransfer member, and/or the like configured to establish fluidcommunication between the transfer adapter 320 and the fluid reservoirs340.

The inner surface 323 defines a set of channels 324 configured to engagea portion of the sterilization member 350 as the housing 345 is insertedinto the inner volume 330. More particularly, the channels 324 canslidably receive a portion of the sterilization member 350 that extendsbeyond the perimeter of the housing 345 (as described above) and candefine a substantially linear range of motion of the housing 345 and thesterilization member 350 relative to the transfer adapter 320. Inaddition, the arrangement of the channels 324 can be such that as thesterilization member 350 is inserted into the channels 324 and thehousing 345 is moved relative to the transfer adapter 320, a portion ofthe inner surface of the transfer adapter 320 defining the channels 324peels, removes, decouples, and/or otherwise disengages the secondportion 357 of the sterilization member 350 from the first portion 356of the sterilization member 350, thereby exposing a surface of the firstportion 356 that is aligned with and/or otherwise covers at least aportion of the opening defined by the housing 345.

For example, in use, a user can place the transfer adapter 320 in fluidcommunication with a lumen-defining device, transfer device, collectiondevice, diversion device, and/or the like, which in turn, is in fluidcommunication with a portion of the body of a patient or an intermediarydevice containing a bodily-fluid, as described in detail above withreference to the transfer adapter 120. Moreover, the housing 345, thefluid reservoirs 340, and the sterilization member 350 can be in a firstconfiguration in which the sterilization member 350 seals the innervolume of the housing 345 such that the fluid reservoirs 340 disposedtherein are maintained in a substantially sterile environment. The usercan manipulate the transfer adapter 320 and/or the housing 345 to insertthe portion of the sterilization member 350 into the channels 324. Asthe user inserts the portion of the sterilization member 350 into thechannels 324, the portion of the inner surface 323 that defines thechannels 323 is placed in contact with the sterilization member 350. Asthe housing 345 is moved relative to the transfer adapter 320, theportion of the inner surface 323 disengages, peels, and/or otherwisedecouples the second portion 357 of the sterilization member 350 fromthe first portion 356 of the sterilization member 350. As such, thesubstantially sterile surface of the first portion 356 that is alignedwith and/or otherwise covers at least a portion of the opening definedby the housing 345 is exposed.

Once the user places the housing 345—and thus, the fluid reservoirs 340disposed therein—in a desired position relative to the transfer adapter320, the user can manipulate the collection device 300 (or portionthereof) to place the transfer adapter 320 in fluid communication withat least one of the fluid reservoirs 340. For example, in someembodiments, the user can actuate an actuator configured to advance apuncture member or the like through a surface of the fluid reservoir340, thereby placing at least one of the fluid reservoirs 340 in fluidcommunication with the patient. Thus, at least one of the fluidreservoirs 340 can receive a flow of bodily-fluid from the patient or anintermediary device containing a bodily-fluid.

The arrangement of the collection device 300 (or portion thereof) issuch that the sterility of the fluid reservoirs 340 within the housing345 and the surface of the first portion 356 of the sterilization member350 is maintained until a time relatively shortly before the transferadapter 320 is placed in fluid communication with the fluid reservoirs340. Similarly, although not shown in FIGS. 3 and 4, the transferadapter 320 can include and/or can be coupled to any suitablesterilization member or mechanism that can be configured to maintain thesterility of, for example, a puncture member or other transfer meansuntil a time relatively shortly before the transfer adapter 320 isplaced in fluid communication with the fluid reservoirs 340. Thus, bymaintaining the sterility of a fluidic interface between the transferadapter 320 and the fluid reservoirs 340 until a relatively short timebefore placing the transfer adapter 320 in fluid communication with thefluid reservoirs, the probability of external contaminants beingtransferred into the bodily-fluid sample received by the fluidreservoirs 340 can be reduced. Moreover, pre-sterilizing fluidicinterfaces and automatically exposing those fluidic interfaces justbefore establishing fluid communication between the transfer adapter 320and the fluid reservoir 340 can increase compliance with sterilizationprotocols and ease of performing the procedure, as well as reduce costsand inadvertent mistakes.

Although the collection device 300 is shown and described above asincluding the housing 345 within which the fluid reservoirs 340 aredisposed and to which the sterilization member 350 is coupled, in otherembodiments, fluid reservoirs need not be disposed within a housing andcan be coupled directly to a sterilization member. For example, FIGS.5-10 illustrate at least a portion of a collection device 400 accordingto another embodiment. As shown in FIG. 5, the collection device 400includes a transfer adapter 420, at least one fluid reservoir 440, andat least one sterilization member 450.

Some aspects of the collection device 400 can be similar in form andfunction to associated aspects of the collection devices 100, 200,and/or 300 (and/or components thereof) described above. For example, theembodiment shown in FIGS. 5-10 illustrates two fluid reservoirs 440,each of which can be similar to or substantially the same as the fluidreservoir 240 described above with reference to FIG. 2. Thus, aspects ofthe collection device 400 similar in form and function to associatedand/or corresponding aspects of the collection devices, and/orcomponents thereof, described above are not described in further detailherein. Moreover, while the collection device 400 is shown in FIG. 5 asincluding the two fluid reservoirs 440 and two sterilization members450, in other embodiments, the collection device 400 can include atransfer adapter configured to receive one fluid reservoir and onesterilization member. In still other embodiments, the collection device400 can include a transfer adapter configured to receive more than twofluid reservoirs and more than two sterilization members. In addition,in the embodiment shown in FIGS. 5-10, the two fluid reservoirs 440 canbe substantially the same unless otherwise indicated and the twosterilization members 450 can be substantially the same unless otherwiseindicated. Thus, a discussion of a single fluid reservoir (e.g., thefluid reservoir 440) and a single sterilization member (e.g., thesterilization member 450) can similarly apply to any number of fluidreservoirs and any number of sterilization members, respectively,included in the collection device 400.

The transfer adapter 420 of the collection device 400 can be anysuitable transfer adapter. For example, in some embodiments, thetransfer adapter 420 can be substantially similar to the transferadapter 120 described above with reference to FIG. 1. Thus, aspects ofthe transfer adapter 420 are not described in further detail herein. Asshown in FIGS. 5 and 6, the transfer adapter 420 includes an innersurface 423 that defines an inner volume 430 configured to receive aportion of the fluid reservoir 440 and at least a portion of thesterilization member 450. Although not shown in FIGS. 5 and 6, thetransfer adapter 420 can include a puncture member, a port, a transfermember, and/or the like configured to establish fluid communicationbetween the transfer adapter 420 and the fluid reservoirs 440.

The inner surface 423 defines a set of channels 424 configured to engagea portion of the sterilization member 450 as the fluid reservoir 440 isinserted into the inner volume 430. For example, the channels 424 canslidably receive a portion of the sterilization member 450 to guide thesterilization member 450 and/or the fluid reservoir 440 to which it iscoupled as the fluid reservoir 440 is moved relative to the transferadapter 420, as described in further detail herein. In addition, thetransfer adapter 420 and/or the inner surface 423 thereof includes anengagement portion 426 configured to engage a seal 457 or the like ofthe sterilization member 450 as the sterilization member 450 is movedrelative to the transfer adapter 420 (e.g., as the portion of thesterilization member 450 is moved within the channels 424 as a result ofthe fluid reservoir 440 being moved relative to the transfer adapter420). For example, the engagement portion 426 can extend from the innersurface 423 and can include a protrusion, tab, flange, etc. configuredto be placed in contact with a portion of the seal 457 of thesterilization member 450. Moreover, the engagement portion 426 isoperable in transitioning the sterilization member 450 from a firstconfiguration to a second configuration, as described in further detailherein.

The sterilization member 450 of the collection device 400 can be anysuitable sterilization member and/or mechanism. In the embodiment shownin FIGS. 5-10, for example, the sterilization member 450 is a cap or thelike coupled to a portion of the fluid reservoir 440. More particularly,the sterilization member 450 defines an inner volume 451 within which ata portion of the fluid reservoir 440 is disposed. In some embodiments,for example, the sterilization member 450 can be coupled to the fluidreservoir 440 during a manufacturing process (e.g., as described abovewith reference to the fluid reservoirs 340 and sterilization member350). In other embodiments, the sterilization member 450 can be coupledto the fluid reservoir 440 prior to use (e.g., by a user). Moreover,when the sterilization member 450 is coupled to the fluid reservoir 440,the sterilization member 450 is configured to maintain a fluidicinterface of the fluid reservoir 440 (e.g., a surface, port, etc.) in asubstantially sterile environment prior to use, as described in furtherdetail herein. For example, in some embodiments, the sterilizationmember 450 can include and/or can be coupled to a pad, a swab, a spongeor porous material, and/or the like that can include a disinfectingagent such as those described herein. In some embodiments, at least asurface of the sterilization member 450 can be impregnated with adisinfecting agent such as, those described above. In some embodiments,the sterilization members 450 can include and/or can define a portionthat is substantially porous, for example, to act as a substrate for thedisinfection agent. In this manner, the sterilization member 450 can bedisposed about a portion of the fluid reservoir 440 to maintain thesterility of the portion of the fluid reservoir 440 prior to use.

As shown in FIG. 7, the sterilization member 450 includes a flange 463having a guide portion 452 and a ramp portion 453. The flange 463extends from the sterilization member 450 such that at least a portionof the flange 463 can be inserted in the channels 424 as thesterilization member 450 is moved within the inner volume 430. Moreover,a portion of the guide portion 452 can, for example, orient thesterilization member 450 relative to the transfer adapter 420 as thesterilization member 450 is inserted into the inner volume 430. Forexample, as shown in FIG. 7, the guide portion 452 can extend from theflange 463 and can include, for example, two protrusions, ribs, tabs,bends, etc. configured to be inserted into a portion of the channels 424of the inner surface 423 having a similar configuration. In other words,the channels 424 defined by the inner surface 423 of the transferadapter 420 are configured to receive an associated sterilization member450 in a predetermined orientation and/or the like. In some embodiments,the arrangement of the guide portion 452 can be associated with aparticular type of fluid reservoir. For example, in some embodiments, asterilization member can include and/or can have a guide portiondisposed on a first side and can be coupled to, for example, an aerobicculture bottle. Conversely, the sterilization member can include and/orcan have a guide portion disposed on a second side, opposite the firstside, and can be coupled to, for example, an anaerobic culture bottle.In other embodiments, a sterilization member need not be associated withpredetermined type of fluid reservoir.

As described above, the sterilization member 450 includes the seal 457.In the embodiment shown in FIGS. 5-10, the seal 457 can be a sheet,foil, tape, and/or the like at least temporarily coupled to a surface ofthe flange 463 and configured to maintain at least a portion of thesurface of the flange 463 in a substantially sterile configuration priorto use. Moreover, as shown, for example, in FIGS. 9-10, thesterilization member 450 can include and/or define an opening 455 orport, which is substantially covered, obstructed, or otherwise incontact with the seal 457. In other words, the seal 457 is at leasttemporarily coupled to a surface of the sterilization member 450 to atleast temporarily fluidically isolate the opening 455 defined by thesterilization member 450, as described in further detail herein.

As shown in FIGS. 7-9, a portion of the seal 457 defines an aperture andis disposed on the ramp portion 453 of the flange 463. The arrangementof the portion of the seal 457 and the ramp portion 453 is such that, asthe sterilization member is moved within the inner volume 430, theportion of the seal 457 disposed on and/or otherwise in contact with theramp portion 453 of the sterilization member 450 is placed in contactwith the engagement portion 426 of the inner surface 423 of the transferadapter 420. The engagement portion 426, therefore, is operable intransitioning the sterilization member 450 from the first configuration(see e.g., FIGS. 5-7) to the second configuration (see e.g., FIGS.8-10), as described in further detail herein.

In use, a user can place the transfer adapter 420 in fluid communicationwith a lumen-defining device, transfer device, collection device,diversion device, and/or the like, which in turn, is in fluidcommunication with a portion of the body of a patient (or intermediarydevice containing a bodily-fluid, as described in detail above withreference to the transfer adapter 120. Moreover, the fluid reservoirs440 and the sterilization member 450 can be in a first configuration inwhich the sterilization member 450 maintains the sterility of at leastthe portion of the fluid reservoir 440 (e.g., a fluidic interface suchas a surface or port).

The user can manipulate the transfer adapter 420 and/or the fluidreservoir 440 to insert the portion of the sterilization member 450 intothe channels 424, as described above with reference to the collectiondevice 300. As the user inserts the portion of the sterilization member450 into the channels 424, the engagement portion 426 of the innersurface 423 is placed in contact with the portion of the seal 457 of thesterilization member 450. More specifically, the ramp portion 453 of thesterilization member 450 defines a channel 454 or slot that exposes theportion of the seal 457 defining the aperture 458. As such, movement ofthe sterilization member 450 (and fluid reservoir 440) within the innervolume 430 disposes the engagement portion 426 (or a protrusionextending therefrom) in the aperture 458 defined by the portion of theseal 457, as shown in FIGS. 8 and 10.

With the engagement portion 426 disposed in the aperture 458, furthermovement of the sterilization member 450 advances the sterilizationmember 450 relative to the engagement portion 426 of the transferadapter 420, which in turn, removes, disengages, peels, and/or otherwisedecouples at least a portion of the seal 457 from the sterilizationmember 450, as shown in FIGS. 8-10. Expanding further, with theengagement portion 426 disposed in the aperture 458 of the seal 457, atleast a portion of the seal 457 is maintained in a substantially fixedposition relative to the transfer adapter 420 as the sterilizationmember 450 is moved within the inner volume 430. Thus, such anarrangement removes, disengages, peels, and/or otherwise decouples aportion of the seal 457 from the surface of the sterilization member450. Moreover, as shown in FIGS. 9 and 10, when the sterilization member450 is disposed in a desired position relative to the transfer adapter420, the seal 457 is sufficiently removed from the surface of thesterilization member 450 such that the opening 455 or port is exposed.

Once the user places the sterilization member 450—and thus, the fluidreservoirs 440 coupled thereto—in the desired position relative to thetransfer adapter 420, the user can manipulate the collection device 400(or portion thereof) to place the transfer adapter 420 in fluidcommunication with at least one of the fluid reservoirs 440. Forexample, in some embodiments, the user can actuate an actuatorconfigured to advance a puncture member or the like through the opening455 of the sterilization member 450 and through a surface or port of thefluid reservoir 440, thereby placing at least one of the fluidreservoirs 440 in fluid communication with the patient or anintermediary device containing a bodily-fluid. While not shown, in otherembodiments, coupling the collection device 400 to the fluid reservoirs440 can automatically facilitate access such that bodily-fluid flowbegins as soon as physical coupling is complete. Thus, the fluidreservoir 440 can receive a flow of bodily-fluid from the patient orintermediary device containing bodily-fluid.

As described above with reference to the collection device 300, thearrangement of the collection device 400 (or portion thereof) is suchthat the sterility of at least the portion of the fluid reservoir 440 incontact with the sterilization member 450 is maintained until a timerelatively shortly before the transfer adapter 420 is placed in fluidcommunication with the fluid reservoir 440. Thus, by maintaining thesterility of a fluidic interface between the transfer adapter 420 andthe fluid reservoir 440 until a relatively short time before placing thetransfer adapter 420 in fluid communication with the fluid reservoirs440, the probability of external contaminants being transferred into thebodily-fluid sample received by the fluid reservoir 440 can be reduced.Moreover, pre-sterilizing fluidic interfaces and automatically exposingthose fluidic interfaces just before establishing fluid communicationbetween the transfer adapter 420 and the fluid reservoir 440 canincrease compliance with sterilization protocols and ease of performingthe procedure, as well as reduce costs and inadvertent mistakes.

Referring now to FIGS. 11-14, a collection device 500 is illustratedaccording to another embodiment. As shown in FIG. 11, the collectiondevice 500 includes a transfer adapter 520, a fluid reservoir 540, and asterilization member 550. Some aspects of the collection device 500 canbe similar in form and function to associated aspects of the collectiondevices 100, 200, 300, and/or 400 (and/or components thereof) describedabove. For example, the embodiment shown in FIGS. 11-14 illustrates thefluid reservoir 540, which can be similar to or substantially the sameas the fluid reservoir 240 described above with reference to FIG. 2.Thus, aspects of the collection device 500 similar in form and functionto associated and/or corresponding aspects of the collection devices,and/or components thereof, described above are not described in furtherdetail herein.

The transfer adapter 520 of the collection device 500 can be anysuitable transfer adapter. For example, in some embodiments, thetransfer adapter 520 can be substantially similar in form and/orfunction to the transfer adapters 120, 220, 320, and/or 420 describedabove. Thus, aspects of the transfer adapter 520 are not described infurther detail herein. As shown in FIG. 11, the transfer adapter 520includes an inner surface 523 that defines an inner volume 530configured to receive a portion of the fluid reservoir 540 and thesterilization member 550. Although not shown in FIGS. 11-14, thetransfer adapter 520 can include a puncture member, a port, a transfermember, and/or the like configured to establish fluid communicationbetween the transfer adapter 520 and the fluid reservoirs 540. Forexample, in some embodiments, the transfer adapter 520 can include apuncture member such as a sheathed needle or the like that can pierce orpuncture a surface 541 of the fluid reservoir 540 (see e.g., FIG. 14) toestablish fluid communication between the transfer adapter 520 and thefluid reservoir 540.

The inner surface 523 includes a first portion 525 and a second portion527. The first portion 525 defines a set of channels 524 configured toengage a portion of the sterilization member 550 as the fluid reservoir540 is inserted into the inner volume 530, as described above withreference to the transfer adapter 320 and 420. For example, the channels524 can slidably receive a portion of the sterilization member 550 toguide the sterilization member 550 and/or the fluid reservoir 540 towhich it is coupled when the fluid reservoir 540 is moved relative tothe transfer adapter 520, as described in further detail herein.

As shown, for example, in FIG. 11, the first portion 525 of the innersurface 523 has a width defined between opposite sides of the firstportion 525 that is less than a width defined between opposite sides ofthe second portion 525. Moreover, the first portion 525 of the innersurface 523 has a depth that is greater than a depth of the secondportion 527 of the inner surface 523. This arrangement of the innersurface 523 forms an edge surface 528 or corner that is associated witha difference between the width of the first portion 525 and the width ofthe second portion 527. The edge surface 528 extends along the depth ofthe second portion 527 and includes, for example, a ramp portion 529 orthe like. As described in further detail herein, a portion of thesterilization member 550 is configured to be placed in contact with theedge surface 528 when the sterilization member 550 is inserted into theinner volume.

The sterilization member 550 of the collection device 500 can be anysuitable sterilization member and/or mechanism. In the embodiment shownin FIGS. 11-14, for example, the sterilization member 550 is a cap orthe like coupled to a portion of the fluid reservoir 540. For example,the sterilization member 550 can be formed from a relatively flexiblematerial and can be coupled to a proximal rim 543 of the fluid reservoir540 via a friction fit, press fit, threaded coupling, and/or the like.As described above, the sterilization member 550 is configured to becoupled to the fluid reservoir 540 to obstruct and/or fluidicallyisolate the surface 541 of the fluid reservoir 540. For example, in someembodiments, the sterilization member 550 can be coupled to the fluidreservoir 540 during a manufacturing process (e.g., as described abovewith reference to the fluid reservoirs 340 and sterilization member350). In other embodiments, the sterilization member 550 can be coupledto the fluid reservoir 540 prior to use (e.g., by a user). Moreover,when the sterilization member 550 is coupled to the fluid reservoir 540,the sterilization member 550 is configured to maintain the surface 541(e.g., a fluidic interface, port, etc.) of the fluid reservoir 540 in asubstantially sterile environment prior to use, as described in detailabove.

As shown in FIGS. 11 and 12, the sterilization member 550 includes acollar 560 or the like having a first portion 561 and a second portion562. The first portion 561 and the second portion 562 of the collar 560can be positioned about a portion of the fluid reservoir 560 and coupled(e.g., via a snap fit, interference fit, etc.) to couple the collar 560to the fluid reservoir 540. Moreover, as shown in FIGS. 11-14, thecollar 560 forms a flange 563 or the like configured to be inserted intothe channels 524 of the transfer adapter 520 as the sterilization member550 is moved within the inner volume 530, as described in detail above.In this manner, the flange 563 can, for example, orient and/or directthe sterilization member 550 relative to the transfer adapter 520 as thesterilization member 550 is inserted into the inner volume 530.

In use, a user can place the transfer adapter 520 in fluid communicationwith a lumen-defining device, transfer device, collection device,diversion device, and/or the like, which in turn, is in fluidcommunication with a portion of the body of a patient (or intermediarydevice containing a bodily-fluid, as described in detail above withreference to the transfer adapter 120. Moreover, the fluid reservoir 540and the sterilization member 550 can be in a first configuration inwhich the sterilization member 550 obstructs, covers, and/or otherwisefluidically isolates the surface 541 of the fluid reservoir tosubstantially maintain the sterility of the surface 541. The user canmanipulate the transfer adapter 520 and/or the fluid reservoir 540 toinsert the flange 563 of the collar 560 into the channels 524, asdescribed above, for example, with reference to the collection device300. As the user inserts the portion of the sterilization member 550into the inner volume 530 of the transfer adapter 520, sterilizationmember 550 is placed in contact with the edge surface 528, as shown inFIG. 13. In some embodiments, coupling the collar 560 about the fluidreservoir 540 and disposing the flange 563 in the channels 524 placesthe sterilization member 550 in a predetermined position (e.g., height)relative to the transfer adapter 520. For example, the predeterminedposition can be a position in which the sterilization member 550 isplaced in contact with the edge surface 528. Thus, as the sterilizationmember 550 is advanced relative to the transfer adapter 520, thesterilization member 550 is placed in contact with the ramp portion 529of the edge surface 528, as shown in FIG. 13.

With the sterilization member 550 in contact with the ramp portion 529of the edge surface 528, further movement of the sterilization member550 into the inner volume 530 advances the sterilization member 550relative to the ramp portion 529, which in turn, removes, disengages,peels, and/or otherwise decouples the sterilization member 550 from thefluid reservoir 540, as shown in FIG. 14. As such, the sterilizationmember 550 is in contact with the edge surface 528 and disposed within aportion of the inner volume 530 defined by the second portion 527 of theinner surface 523. With the sterilization member 550 decoupled from thefluid reservoir 540, the fluid reservoir 540 can be moved within theinner volume 530 relative to the sterilization member 550 and placed ina desired position. For example, the fluid reservoir 540 can be advancedwithin the inner volume 530 to a depth that is substantially beyond thesecond portion 527 of the inner surface 523, as shown in FIG. 14.

With the sterilization member 550 decoupled from the fluid reservoir540, the surface 541 of the fluid reservoir 540 is substantiallyexposed. In some embodiments, the desired position of the fluidreservoir 540 within the transfer adapter 520 can substantially align aportion of the surface 541 (e.g., a port or other fluidic interface)with a transfer member (e.g., a puncture member such as a sheathedneedle or the like). Thus, with the fluid reservoir 540 in the desiredposition relative to the transfer adapter 520, the user can manipulatethe collection device 500 (or portion thereof) to place the transferadapter 520 in fluid communication with the fluid reservoir 540. Forexample, in some embodiments, the user can actuate an actuatorconfigured to advance a puncture member or the like through a port orfluidic interface of the surface 541 of the fluid reservoir 540, therebyplacing the fluid reservoir 540 in fluid communication with the patient.While not shown, in other embodiments, the physical process of couplingthe collection device 500 to the fluid reservoir 540 via the transferadapter 520 automatically facilitates a flow path for bodily-fluidwithout specific user manipulation. Thus, the fluid reservoir 540 canreceive a flow of bodily-fluid from the patient or intermediary devicecontaining a bodily fluid.

As described above with reference to the collection device 300, thearrangement of the collection device 500 (or portion thereof) is suchthat the sterility of at least the surface 541 of the fluid reservoir540 is maintained until a time relatively shortly before the transferadapter 520 is placed in fluid communication with the fluid reservoir540. Thus, by maintaining the sterility of a fluidic interface betweenthe transfer adapter 520 and the fluid reservoir 540 until a relativelyshort time before placing the transfer adapter 520 in fluidcommunication with the fluid reservoirs, the probability of externalcontaminants being transferred into the bodily-fluid sample received bythe fluid reservoir 540 can be reduced. Moreover, pre-sterilizingfluidic interfaces and automatically exposing those fluidic interfacesjust before establishing fluid communication between the transferadapter 520 and the fluid reservoir 540 can increase compliance withsterilization protocols and ease of performing the procedure, as well asreduce costs and inadvertent mistakes.

As described above, the transfer adapters 120, 220, 320, 420, and 520can be included in and/or coupled to any suitable device configured toreceive a fluid of bodily-fluid from a patient. Such devices can be anysuitable collection device, transfer device, diversion device, and/orthe like. For example, FIGS. 15-17 illustrate a collection device 600according to an embodiment. The collection device 600 can be anysuitable device configured to withdraw and/or receive bodily-fluid froma patient. Moreover, the collection device 600 can be used inconjunction with any of the transfer adapters, sterilization members,and/or fluid reservoirs described herein. In other embodiments, thearrangement of the collection device 600 can minimize fluid interfacesor the like, which in turn, can reduce a likelihood of a sample becomingcontaminated by external contaminants.

As shown in FIGS. 15-17, the collection device 600 includes and/or formsa handle 610 having a proximal end portion 611 and a distal end portion612. The distal end portion 612 of the handle 610 can include and/or canbe coupled to any suitable port 614 or the like configured to be placedin fluid communication with one or more fluid reservoirs. For example,as shown in FIG. 16, the proximal end portion 611 of the handle 610includes at least two ports 614 configured to be physically andfluidically coupled to one or more fluid reservoirs 670A and 670B. Thefluid reservoirs 670A and/or 670B can be, for example, evacuatedreservoirs such as a Vacutainer® or the like. In some embodiments, thefluid reservoirs 670A and/or 670B can be configured to receive apre-sample volume of bodily-fluid that can contain, for example,dermally-residing microbes, external contaminants or the like. In otherembodiments, the fluid reservoirs 670A and/or 670B can receive a samplevolume of bodily-fluid, which subsequently can be used in any suitabletesting process or the like.

The distal end portion 612 includes a coupler 613 or the like configuredto be physically and fluidically coupled to any suitable transferadapter such as, for example, those described herein. In otherembodiments, the coupler 613 can form an integrated transfer adapter orthe like. As such, the coupler 613 is configured to be at leastindirectly physically and fluidically coupled to any suitable deviceand/or mechanism configured to transfer bodily-fluid to and/or from thecollection device 600, as described in further detail herein.

The handle 610 also includes a system actuator 615 configured toinitiate, modulate, divert, and/or otherwise control a flow of thebodily-fluid through the handle 610. Although not shown in FIGS. 15-17,the handle 610 can include any suitable internal component, mechanism,reservoir, or the like configured to facilitate the transfer ofbodily-fluid through the handle 610. For example, in some embodiments,the system actuator 615 can be coupled to and/or otherwise include anysuitable device, mechanism, assembly, member, etc. operable inselectively limiting, controlling, regulating, diverting, etc. a flow ofthe bodily-fluid. Specifically, although not shown in FIGS. 15-17, thehandle 610 can include any suitable flow control mechanism that cancontrol a flow of the bodily-fluid into and/or from one or more fluidreservoirs 619 disposed within the handle 610. In some embodiments, sucha flow control mechanism can be any of those described in the ‘241patent, the ‘724 patent, the ‘864 patent, and/or the ‘495 patent, eachof which is incorporated by reference above. In some embodiments, suchfluid reservoirs 619 can be, for example, evacuated containers or thelike such as a Vacutainer®. In other embodiments, the system actuator615 can include a plunger or the like that can move inside a fluidreservoir to increase an inner volume of the fluid reservoir. Theincrease in volume can produce a negative pressure within the innervolume of the fluid reservoir, which in turn, can draw bodily-fluid intothe fluid reservoir. In some embodiments, actuating the system actuator615 can be operable in diverting a pre-sample volume of bodily-fluidinto a pre-sample reservoir (not shown) and once transferred,sequestering the pre-sample volume of bodily-fluid within the pre-samplereservoir. In this manner, a subsequent volume of bodily-fluid withdrawnfrom the patient into the fluid reservoirs 619 can be substantially freefrom dermally-residing microbes, external microbes or other contaminantssequestered in the pre-sample reservoir. In some embodiments, actuatingthe system actuator 615 can be operable in diverting a pre-sample volumeof bodily-fluid into, for example, at least one of the fluid reservoirs670A and/or 670B.

The coupler 613 of the handle 610 can be coupled to any suitable device.For example, as shown in FIGS. 15 and 16, the coupler 613 is coupled toa lumen-defining device 616 such as sterile flexible tubing. Thelumen-defining device 616 can include a needle 618 or cannula disposedat a first end of the lumen-defining device 616 that is configured topuncture or pierce the skin of a patient to place the lumen-definingdevice 616 in fluid communication with the patient. While not shown, inother embodiments, the lumen-defining device 616 can be substantiallysimilar to standard peripheral IV catheter, which can facilitate accessto a patient's bloodstream and/or other bodily-fluid source. Thelumen-defining device 616 also includes an adapter 617 at a second endthat can physically and fluidically couple the lumen-defining device 616to the coupler 613 of the handle 610. The adapter 617 and the coupler613 can be coupled in any suitable manner such as, for example, a pressfit, a friction fit, a set of tabs, and/or the like. In someembodiments, the coupler 613 can define a set of channels or the likewithin which a portion of the adapter 617 can be inserted. In suchembodiments, the portion of the adapter 617 can be inserted in to thechannels of the coupler 613 and slid therein to a desired positionrelative to the handle 610. As described above with reference to thehousing 345, in some embodiments, the adapter 617 can include asterilization member or the like that can be transitioned, for example,from a first configuration, in which the sterility of an interface ofthe adapter 617 is maintained, to a second configuration, in which atleast a portion of the sterilization member is removed from the adapter617. Moreover, coupling the adapter 617 to the coupler 613 can place thehandle 610 in fluid communication with the lumen-defining device 616.Thus, bodily-fluid can be transferred from a patient to the fluidreservoirs 619 disposed within the handle 610 in response to, forexample, a user actuating the system actuator 615.

In a similar manner, the coupler 613 can be at least indirectly coupledto one or more fluid reservoirs 640A and/or 640B. For example, as shownin FIG. 17, the adapter 617 coupled to the lumen-defining device 616 canbe removed from the coupler 613 and an adapter 646 coupled to the fluidreservoirs 640A and 640B can be coupled to the coupler 613. In someembodiments, the adapter 646 can be coupled to the coupler 613 in asubstantially similar manner as described with reference to the adapter617. Thus, when the adapter 646 is coupled to the coupler 613, the fluidreservoirs 640A and/or 640B can be placed in fluid communication with,for example, one or more fluid reservoirs within the handle 610.

As shown in FIG. 17, the adapter 646 is coupled to and/or disposed aboutat least a portion of the fluid reservoirs 640A and 640B. In someembodiments, the adapter 646 can be similar in form and/or function to,for example, the housing 345 shown in FIGS. 3 and 4. In this manner, theadapter 646 can include a sterilization member or the like configured todefine at least a portion of a sterile environment within which at leastthe portion of the fluid reservoirs 640A and 640B can be disposed, asdescribed above with reference to the housing 345 and the sterilizationmember 350 of FIGS. 3 and 4.

In some embodiments, the adapter 646 can include an actuator 647, whichcan direct a flow of bodily-fluid from the fluid reservoir(s) 619 withinthe handle 610 and through the adapter 646 when actuated. In otherwords, the actuator 647 of the adapter 646 can selectively place thefluid reservoirs 640A and/or 640B in fluid communication with thecoupler 613 of the handle 610. In some embodiments, coupling the adapter646 to the coupler 613 can automatically establish fluid communicationbetween the fluid reservoirs 640A and/or 640B and the handle 610. Forexample, in some embodiments, the coupler 613 can include one or morepuncture members configured to puncture a portion of the adapter 646 andthe fluid reservoir(s) 640A and 640B when the adapter 646 is coupledthereto. In other embodiments, the coupling of the adapter 646 to thecoupler 613 at least partially removes and/or decouples a sterilizationmember such that an inlet surface, interface, and/or the like of thefluid reservoir(s) 640A and/or 640B is unobstructed. In suchembodiments, the puncture members of the coupler 613 need not puncture aportion of the adapter 646 in conjunction with and/or prior topuncturing, for example, an inlet surface of the fluid reservoirs 640Aand/or 640B. Thus, bodily-fluid stored within the fluid reservoir(s) 619in the handle 610 can be transferred to the fluid reservoirs 640A and/or640B, which in turn, can be used in any suitable testing and/or analysisprocess.

In some instances, reducing a number of fluidic interfaces along a fluidflow path can reduce a likelihood of contaminants being transferred intoa volume of bodily-fluid flowing within the fluid flow path. Thus, themodular arrangement of the collection device 600 can result in areduction of contaminants in the bodily-fluid that is ultimatelytransferred into the fluid reservoirs 640A and/or 640B. Although notshown in FIGS. 15-17, any of the components (e.g., the coupler 613and/or the adapters 617 and 646) can include any suitable sterilizationmember such as those described above. As such, the sterility of thefluidic interfaces can be maintained until the collection device 600 isplaced in a configuration associated with transferring a bodily-fluid toand/or from the handle 610. Additionally, at least some or all of thecomponents depicted in FIGS. 15-17 can be pre-assembled during amanufacturing process and sterilized using standard medical techniques(e.g. ethylene oxide, gamma radiation, e-beam or the like) to maintainsterility of the enclosed collection device and/or sample reservoirs.

FIGS. 18-21 illustrate a collection device 700 according to anotherembodiment. The collection device 700 can be any suitable deviceconfigured to withdraw and/or receive bodily-fluid from a patient.Moreover, the collection device 700 can be used in conjunction with anyof the transfer adapters, sterilization members, and/or fluid reservoirsdescribed herein. In some embodiments, the arrangement of the collectiondevice 700 can minimize fluid interfaces or the like, which in turn, canreduce a likelihood of a sample becoming contaminated by externalcontaminants. Some aspects of the collection device 700 can besubstantially similar in form and/or function to the associated aspectsof the collection device 600 described above with reference to FIGS.15-17. Thus, such similar aspects are not described in further detailherein.

As shown in FIGS. 18-21, the collection device 700 includes and/or formsa handle 710 having a proximal end portion 711 and a distal end portion712. The handle 710 also includes a system actuator 715 configured toinitiate, modulate, divert, and/or otherwise control a flow of thebodily-fluid through the handle 710 and one or more fluid reservoirs 719configured to receive and at least temporarily store a volume ofbodily-fluid. Although not shown in FIGS. 18-21, the handle 710 caninclude any suitable internal component, mechanism, device, or the likeconfigured to facilitate the transfer of bodily-fluid through the handle710, as described in detail above with reference to the handle 610.

The proximal end portion 711 of the handle 710 can include and/or can becoupled to any suitable port or the like configured to be placed influid communication with the fluid reservoir(s) 719 disposed within thehandle 710, as described above with reference to the handle 610. Thedistal end portion 712 includes a coupler 713 or the like configured tobe physically and fluidically coupled to any suitable transfer adaptersuch as, for example, those described herein. In other embodiments, thecoupler 713 can form an integrated transfer adapter or the like. Assuch, the coupler 713 is configured to be at least indirectly physicallyand fluidically coupled to any suitable device and/or mechanismconfigured to transfer bodily-fluid to and/or from the collection device700, as described in further detail herein.

The coupler 713 of the handle 710 can be coupled to any suitable device.For example, as shown in FIGS. 18 and 19, the coupler 713 is coupled toa lumen-defining device 716 such as sterile flexible tubing. Thelumen-defining device 716 can include a needle 718 or cannula disposedat a first end of the lumen-defining device 716 that is configured topuncture or pierce the skin of a patient to place the lumen-definingdevice 716 in fluid communication with the patient. While not shown, inother embodiments, the lumen-defining device 716 can be substantiallysimilar to standard peripheral IV catheter, which can facilitate accessto a patient's bloodstream and/or other bodily-fluid source. Thelumen-defining device 716 also includes an adapter 717 at a second endconfigured to be physically and fluidically coupled to the coupler 713of the handle 710. The adapter 717 and the coupler 713 can be coupled inany suitable manner such as, for example, a press fit, a friction fit, aset of tabs, and/or the like. In some embodiments, the coupler 713 candefine a set of channels or the like within which a portion of theadapter 717 can be inserted. As described in detail above with referenceto the collection device 600, coupling the adapter 717 to the coupler713 can place the handle 710 in fluid communication with thelumen-defining device 716. Thus, bodily-fluid can be transferred from apatient to the fluid reservoir(s) 719 in response to, for example, auser actuating the system actuator 715.

As shown in FIG. 19, a fluid reservoir 770A (e.g., an external fluidreservoir and/or a pre-sample reservoir) can be coupled to the adapter717 prior to the adapter 717 being coupled to the coupler 713 and/orafter the adapter 717 is removed from the coupler 713. In other words,the fluid reservoir 770A can be a pre-sample reservoir or the likeconfigured to receive a pre-sample volume of bodily-fluid. In someinstances, transferring a volume of bodily-fluid to the fluid reservoir770A prior to coupling the adapter 717 to the coupler 713 can, forexample, entrain contaminants within the flow of bodily-fluid, which inturn, can be sequestered in the fluid reservoir 770A. In such instances,once a desired volume of bodily-fluid is transferred into the fluidreservoir 770A, the fluid reservoir 770A can be removed from the adapter717, which can then be coupled to the coupler 713. Thus, by sequesteringa first volume of bodily-fluid in the fluid reservoir 770A, a subsequentvolume of bodily-fluid transferred to one or more fluid reservoir(s) 719disposed within the handle 710 can be substantially free fromdermally-residing microbes, external contaminants, or the like. In otherembodiments, the fluid reservoir 770A can receive a volume ofbodily-fluid that can be used for additional testing and/or the like.

As described above with reference to the collection device 600, after avolume of bodily-fluid is transferred to the fluid reservoir(s) 719disposed within the handle 710, the coupler 713 can be at leastindirectly coupled to one or more fluid reservoirs 740A and/or 740B(e.g., external fluid reservoirs and/or sample reservoirs). For example,as shown in FIG. 20, the adapter 717 coupled to the lumen-definingdevice 716 can be removed from the coupler 713 and an adapter 746coupled to the fluid reservoirs 740A and 740B can be coupled to thecoupler 713. In some embodiments, the adapter 746 can be coupled to thecoupler 713 in a substantially similar manner as described withreference to the adapter 717. In some embodiments, the adapters 717and/or 746 can include and/or can be at least temporarily coupled to asterilization member configured to maintain the sterility of, forexample, an interface of the adapters 717 and/or 746 prior to beingcoupled to the coupler 713, as described above with reference to theadapters 617 and 646.

When the adapter 746 is coupled to the coupler 713, the fluid reservoirs740A and/or 740B can be placed in fluid communication with, for example,the one or more fluid reservoirs 719 within the handle 710. As describedabove, the adapter 746 can include an actuator 747 that can direct aflow of bodily-fluid from the fluid reservoir(s) 719 within the handle710 and through the adapter 746 when actuated. In other words, theactuator 747 of the adapter 746 can selectively place the fluidreservoirs 740A and/or 740B in fluid communication with the coupler 713and/or the fluid reservoirs 719 within the handle 710. Thus,bodily-fluid stored within the fluid reservoir(s) 719 in the handle 710can be transferred to the fluid reservoirs 740A and/or 740B, which inturn, can be used in any suitable testing and/or analysis process, asdescribed above with reference to the collection device 600.

As shown in FIG. 21, in some embodiments, an additional reservoir 770Bcan be physically and fluidically coupled to the adapter 746. Forexample, in some instances, a relatively large volume of bodily-fluidcan be withdrawn from the patient, which can, for example, allow for theadditional fluid reservoir 770B to be coupled to the adapter 746. Thus,a volume of the bodily-fluid can be transferred into the additionalfluid reservoir 770B that can subsequently be used for additionaltesting or the like. Moreover, in some embodiments, the actuator 747included in the adapter 746 can be configured to control a flow ofbodily fluid from the reservoir(s) disposed within the handle 710 to thefluid reservoirs 740A, 740B, and/or 770B.

FIGS. 22-24 illustrate a collection device 800 according to anotherembodiment. The collection device 800 can be any suitable deviceconfigured to withdraw and/or receive bodily-fluid from a patient.Moreover, the collection device 800 can be used in conjunction with anyof the transfer adapters, sterilization members, and/or fluid reservoirsdescribed herein. In some embodiments, the arrangement of the collectiondevice 800 can minimize fluid interfaces or the like, which in turn, canreduce a likelihood of a sample becoming contaminated by externalcontaminants. Some aspects of the collection device 800 can besubstantially similar in form and/or function to the associated aspectsof the collection device 600 and/or 700 described above with referenceto FIGS. 15-17 and FIGS. 18-21, respectively. Thus, such similar aspectsare not described in further detail herein.

The collection device 800 includes and/or forms a handle 810 having aproximal end portion 811 and a distal end portion 812. The proximal endportion 811 of the handle 810 can include and/or can be coupled to anysuitable port or the like configured to be placed in fluid communicationwith one or more fluid reservoirs, as described above with reference tothe handle 610. As shown, the distal end portion 812 of the handle 810is physically and fluidically coupled to a lumen-defining device 816such as sterile flexible tubing. The lumen-defining device 816 caninclude a needle 818 or cannula disposed at a first end of thelumen-defining device 816 that is configured to puncture or pierce theskin of a patient to place the lumen-defining device 816 in fluidcommunication with the patient. A second end of the lumen-definingdevice 816 is fixedly coupled to the distal end portion 812 of thehandle 810. That is to say, the lumen-defining device 816 can beintegrated into the handle 810 and/or otherwise not coupled to anadapter, which in turn, would otherwise be coupled to a coupler of thehandle 810 (e.g., as described above with reference to thelumen-defining devices 616 and 716). Thus, as described in detail abovewith reference to the collection devices 600 and 700, the lumen-definingdevice 816 can transfer bodily-fluid from a patient to one or more fluidreservoir(s) 819 disposed within the handle 810, as described in furtherdetail herein.

The handle 810 also includes a coupler 813 and a system actuator 815.The system actuator 815 is configured to initiate, modulate, divert,and/or otherwise control a flow of the bodily-fluid through the handle810. Although not shown in FIGS. 22-24, the handle 810 can include anysuitable internal component, mechanism, device, fluid reservoir, or thelike configured to facilitate the transfer of bodily-fluid through thehandle 810, as described in detail above with reference to the handle610. Thus, actuating the system actuator 815 can transfer bodily-fluidfrom a patient, through the lumen-defining device 816, and into the oneor more fluid reservoirs 819 disposed within the handle 810.

As described above with reference to the collection devices 600 and 700,the coupler 813 is configured to be physically and fluidically coupledto any suitable transfer adapter such as, for example, those describedherein. In other embodiments, the coupler 813 can form an integratedtransfer adapter or the like. While the couplers 613 and 713 are shownand described above as being included in and/or disposed at a distal endportion 612 and 712, respectively, of the handles 610 and 710,respectively, in the embodiment shown in FIGS. 22-24, the coupler 813can be disposed at or near the proximal end portion 811 of the handle810 and/or at any other suitable location along the handle 810 (e.g.,along a top surface of the handle 810, a bottom surface of the handle810, and/or along a side surface of the handle 810).

The coupler 813 is configured to be physically and fluidically coupled(at least indirectly) to any suitable device and/or mechanism configuredto transfer bodily-fluid to and/or from the collection device 800. Forexample, as shown in FIGS. 22 and 23, the coupler 813 can be at leastindirectly coupled to one or more fluid reservoirs 840A and/or 840B.More specifically, an adapter 846 coupled to the fluid reservoirs 840Aand 840B can be coupled to the coupler 813. In some embodiments, theadapter 846 can be coupled to the coupler 813 in a substantially similarmanner as described above with reference to the adapter 646. In someembodiments, the adapter 846 can include and/or can be at leasttemporarily coupled to a sterilization member configured to maintain thesterility of, for example, an interface of the adapter 846 prior tobeing coupled to the coupler 813, as described above with reference tothe adapters 617 and 646. Thus, when the adapter 846 is coupled to thecoupler 813, the fluid reservoirs 840A and/or 840B can be placed influid communication with, for example, one or more fluid reservoirs 819within the handle 810.

Although the adapters 646 and 746 are described above as having anactuator, in the embodiment illustrated in FIGS. 22-24, the coupler 813of the handle 810 includes an actuator 835. As described above, theactuator 835 can be configured to direct a flow of bodily-fluid from thefluid reservoir(s) within the handle 810 and through the adapter 846. Inother words, the actuator 835 of the coupler 813 can selectively placethe fluid reservoirs 840A and/or 840B in fluid communication with thehandle 810. Thus, bodily-fluid stored within the fluid reservoir(s) 819in the handle 810 can be transferred to the fluid reservoirs 840A and/or840B, which in turn, can be used in any suitable testing and/or analysisprocess, as described above with reference to the collection device 600.

As described above with reference to the portion of the collectiondevice 300, the embodiment shown in FIGS. 22-24 includes a sterilizationmember 850 coupled to the adapter 846. For example, the sterilizationmember 850 can be a sheet, film, foil, wipe, seal, and/or the likeconfigured to at least temporarily fluidically isolate a portion theadapter 846. Thus, as described above, the sterilization member 850 canbe configured to seal the adapter 846 to maintain a portion of the fluidreservoirs 840A and 840B in a substantially sterile environment prior touse. In some embodiments, coupling the adapter 846 to the coupler 813can include disposing at least a portion of the sterilization member 850through a set of channels or the like (not shown). As described indetail above with reference to the sterilization member 350, a surfaceof the coupler 813 defining at least a portion of the channels canengage the sterilization member 850 to remove at least a portion of theadapter 846. Thus, a portion of the fluid reservoirs 840A and 840B canbe exposed and placed in fluid communication with the handle 810, asdescribed above.

As shown in FIG. 24, in some embodiments, an additional reservoir 870can be physically and fluidically coupled to the coupler 813. Forexample, in some instances, a relatively large volume of bodily-fluidcan be withdrawn from the patient, which can, for example, allow for theadditional fluid reservoir 870 to be coupled to the coupler 813. Thus, avolume of the bodily-fluid can be transferred into the additional fluidreservoir 870 that can subsequently be used for additional testing orthe like. In other embodiments, the additional fluid reservoir 870 canbe coupled to the adapter 846. In some embodiments, the actuator 835included in the coupler 813 can be configured to control a flow ofbodily fluid from the reservoir(s) 819 disposed within the handle 810 tothe fluid reservoirs 840A, 840B, and/or 870.

In some embodiments, the actuator 815 can be configured to remain in alocked configuration until a volume of bodily-fluid is transferred into,for example, the fluid reservoir 870 (e.g., a pre-sample reservoir).Thus, in some instances, contaminants contained in a fluid flow pathdefined between the fluid reservoir(s) 819 within the handle 810 and thecoupler can be transferred into the fluid reservoir 870. In suchinstances, after the volume of bodily-fluid is transferred into thefluid reservoir 870, the fluid reservoir 870 can be removed from thecoupler 813, which in turn, can sequester the contaminants in the fluidreservoir 870. Thus, subsequent volumes of bodily-fluid transferred tothe fluid reservoirs 840A and/or 840B can be substantially free fromcontaminants. Moreover, disposing the actuator 815 in a lockedconfiguration prior to a volume of bodily-fluid being transferred intothe fluid reservoir 870 can ensure a user first collects the volume ofbodily-fluid in the fluid reservoir 870, which can reduce an amount ofcontaminants transferred into the fluid reservoirs 840A and 840B, asdescribed above.

While the handles 610, 710, and 810 are each described above asincluding the coupler 613, 713, and 813, respectively, that isconfigured to couple to an adapter, in other embodiments, a handle caninclude multiple couplers each of which can be coupled to an adapter.For example, in some embodiments, a handle can include a first couplerdisposed at, for example, a distal end portion of the handle (e.g.,similar to the couplers 613 and 713 described above). The first couplercan be configured to couple to an adapter in fluid communication with,for example, a lumen-defining device that can be placed in fluidcommunication with one or more fluid reservoirs disposed within thehandle when coupled to the first coupler. The handle can also include asecond coupler disposed at, for example, a proximal end portion of thehandle (e.g., similar to the coupler 813 described above). The secondcoupler can be configured to couple to an adapter in fluid communicationwith, for example, one or more sample reservoirs that can be placed influid communication with the one or more fluid reservoirs disposedwithin the handle when coupled to the second coupler. In suchembodiments, a volume of bodily-fluid can be transferred from thepatient into the one or more fluid reservoirs within the handle, asdescribed above with reference to the handles 610, 710, and/or 810. Avolume of the bodily-fluid within the one or more fluid reservoirswithin the handle can then be transferred into the sample reservoirscoupled to the second coupler, as described above with reference to thehandles 610, 710, and/or 810.

FIG. 25 is a flowchart illustrating a method 10 of parentally-procuringbodily-fluid samples with reduced contamination, according to anembodiment. The method 10 includes establishing fluid communicationbetween a patient and a first fluid reservoir, at 11. The first fluidreservoir can be any suitable fluid reservoir such as those describedherein. In some embodiments, for example, the first fluid reservoir canbe a fluid reservoir disposed within a handle (e.g., the handles 610,710, and/or 810) and/or any other suitable fluid transfer device.

In some embodiments, the first fluid reservoir can be in fluidcommunication with a lumen-defining device or the like that defines atleast a portion of a fluid flow path between the patient and the firstfluid reservoir. For example, the lumen-defining device can be coupledto and/or can include a needle at a first end and can be coupled to thefirst fluid reservoir and/or other suitable flow path at a second end(e.g., opposite the first end), as described above with reference to thecollection device 800. In some embodiments, the lumen-defining devicecan be coupled to and/or included in an adapter or the like configuredto couple to a portion of a fluid transfer device that includes thefirst fluid reservoir, as described above with reference to thecollection devices 600 and/or 700. In some embodiments, fluidcommunication between the first fluid reservoir and the lumen-definingdevice (and thus, the patient) can be in response to, for example, anactuation of an actuator or the like, as described above with referenceto the collection devices 600, 700, and/or 800.

Once fluid communication is established between the first fluidreservoir and the patient, a volume of bodily-fluid can be withdrawnfrom the patient and into the first fluid reservoir, at 12.Alternatively, as described above, the method 10 can optionally includewithdrawing a pre-sample volume of bodily-fluid into one or morepre-sample reservoirs prior to transferring the volume of bodily-fluidto the first fluid reservoir. The pre-sample volume can then besequestered in the pre-sample volume prior to transferring thebodily-fluid to the first fluid reservoir. In some instances,transferring bodily-fluid to the first fluid reservoir can be blockedand/or substantially prevented until a pre-sample volume has beensequestered in a pre-sample reservoir.

With the volume of bodily-fluid contained in the first fluid reservoir,a second fluid reservoir is coupled to a transfer adapter in fluidcommunication with the first fluid reservoir, at 13. The transferadapter can be any of those described herein. In some embodiments, thetransfer adapter can be substantially similar to the coupler 613described above with reference to FIGS. 15-17. The second fluidreservoir can be any suitable fluid reservoir such as those describedherein. In some embodiments, a portion of the second fluid reservoir canbe coupled to, for example, a sterilization member or the likeconfigured to maintain the sterility of an inlet surface of the secondfluid reservoir. The sterilization member can be substantially similarto any of those described herein. As such, the sterilization member candefine at least a portion of a sterile environment in which the inletsurface of the second fluid reservoir is disposed.

The sterilization member is moved relative to the inlet surface of thesecond fluid reservoir such that fluid communication can be establishedbetween the second fluid reservoir and the transfer adapter, at 14. Forexample, in some embodiments, the transfer adapter can include asurface, a feature, a contour, a protrusion, etc. configured to beplaced in contact with the sterilization member as the second fluidreservoir is coupled to the transfer adapter (e.g., occurring atsubstantially the same time and/or in a single process). In this manner,as the second fluid reservoir moves relative to the transfer adapter tocouple thereto, the sterilization member is moved, for example, from afirst configuration to a second configuration. In some embodiments, forexample, the sterilization member can be at least partially removed fromthe second fluid reservoir such that the inlet surface is substantiallyunobstructed, as described in detail above with reference to specificembodiments.

With the inlet surface of the second fluid reservoir substantiallyunobstructed, fluid communication is established between the first fluidreservoir and the second fluid reservoir, at 15. For example, in someembodiments, a user or the like can actuate an actuator that can beoperable to define a fluid flow path between the first fluid reservoirand the second fluid reservoir. In some embodiments, such an actuationof the actuator can, for example, advance one or more puncture membersrelative to the second fluid reservoir such that a portion of thepuncture member punctures or pierces the inlet surface of the secondfluid reservoir, as described above. In some embodiments, multipleactuators can be actuated to establish fluid communication between thefirst fluid reservoir and the second fluid reservoir. Once fluidcommunication is established between the first fluid reservoir and thesecond fluid reservoir, a volume of bodily-fluid is transferred from thefirst fluid reservoir to the second fluid reservoir, at 16. In someinstances, maintaining the sterility of at least a portion of the fluidreservoir prior to use and/or maintaining the sterility of one or moreinterfaces which are coupled to define at least a portion of a fluidflow path, can result in reduced contamination within a sample volume ofbodily-fluid transferred to the second fluid reservoir. Similarly,withdrawing a pre-sample volume of bodily-fluid into a pre-samplereservoir and sequestering the pre-sample volume within the pre-samplereservoir can also reduce contaminants that may otherwise be present ina sample volume transferred to the second fluid reservoir.

Any of the embodiments described herein can include components that aremanufactured, packaged, and sold independently or collectively. Forexample, in some instances, any of the embodiments described herein canbe manufactured, assembled, and packaged collectively during amanufacturing process. In such instances, one or more sterilizationmembers, such as those described herein, can be positioned within acollection device and/or coupled to a sample reservoir during amanufacturing process (e.g., during assembly), which can be performed,for example, in a substantially sterile environment and/or facilitatedusing post-manufacturing standard medical sterilization techniques (e.g.ethylene oxide, gamma radiation, e-beam, or the like). Moreover, theposition of the sterilization member can be such that during use, aclinician is substantially prevented from collecting and/or transferringa bodily-fluid sample into a fluid reservoir(s) without engaging thesterilization member to at least substantially sterilize a connectionbetween the collection device and the fluid reservoir.

Although not shown, any of the embodiments and/or methods describedherein can be used in conjunction with and/or otherwise in the methodsdescribed in the ‘782 publication incorporated by reference above. Forexample, the embodiments, described herein can be used to collect abodily-fluid sample, which in turn can be used in any of the testingmethods, diagnostic methods, and/or analysis methods described in the‘782 publication.

While various embodiments have been described above, it should beunderstood that they have been presented by way of example only, and notlimitation. For example, although not shown, the embodiments and/ormethods described herein can be used with any suitable fluid transferdevice configured to receive a flow of bodily-fluid from a patient andat least temporarily store and/or otherwise transfer at least a portionof the bodily-fluid to one or more sample reservoirs. Similarly, in someembodiments, such a fluid transfer device can be used to transferbodily-fluid to a transfer adapter such as those described herein, whichin turn, can transfer at least a portion of the bodily-fluid to one ormore fluid reservoirs (e.g., sample reservoirs). In some embodiments,such a fluid transfer device can be any of those described in the ‘241patent, the ‘724 patent, the ‘864 patent, the ‘495 patent, and/or the‘782 publication.

For example, in some instances, the embodiments described herein can beused with a syringe-based fluid transfer device. In some such instances,the use of a syringe-based device can allow a user to manually control aflow of bodily-fluid into a syringe (e.g., the transfer device) bymodulating a force exerted on an actuator or plunger. For example, insome instances, a user can control a rate of fluid transfer and/or anamount of negative pressure, which, in the case of drawing a volume ofblood, can limit and/or reduce a risk of hemolysis of the volume ofblood, a risk of vein collapse, a risk of inaccurate volume collection,and/or the like. In some embodiments, such a syringe-based transferdevice can be similar to any of those described in the ‘495 patent. Insome embodiments, once a desired volume of bodily-fluid (e.g., blood) isdrawn into the syringe-based device, any of the transfer adapters and/orfluid reservoirs (with or without sterilization members coupled thereto)can be coupled to and/or placed in fluid communication with thesyringe-based device such that a desired volume of bodily-fluid can betransferred into one or more fluid reservoirs (e.g., sample reservoirs).In other embodiments, any of the transfer adapters and/or devicesdescribed herein can be integrated into and/or otherwise included in asyringe-based transfer device.

While the embodiments have been particularly shown and described, itwill be understood that various changes in form and details may be made.Where schematics and/or embodiments described above indicate certaincomponents arranged in certain orientations or positions, thearrangement of components may be modified. Although various embodimentshave been described as having particular features and/or combinations ofcomponents, other embodiments are possible having a combination of anyfeatures and/or components from any of embodiments as discussed above.

By way of example, while the sterilization members 150, 350, 450, 550,650, 750, and/or 850 have been described above as substantiallymaintaining the sterility of a surface of a fluid reservoir, in otherembodiments, any of the sterilization members described herein can beused to disinfect a surface of a fluid reservoir. For example, in someembodiments, any of the sterilization members can be coupled to aportion of a fluid reservoir in a substantially sterile environmentduring a manufacturing process or the like such as those describedherein. Thus, in such embodiments, the sterilization members can beconfigured to maintain the sterility of the portion of the fluidreservoir. In other embodiments, however, any of the sterilizationmembers described herein can be coupled to a portion of a fluidreservoir in a non-sterile environment during a manufacturing processand/or by a user prior to use. Thus, in such embodiments, thesterilization members can be configured to disinfect the portion of thefluid reservoir (e.g., an inlet surface or the like) and/or otherwiseremove contaminants from the portion of the fluid reservoir.Accordingly, while described above as “sterilization members” configuredto maintain the sterility of a portion of a fluid reservoir, it shouldbe understood that such members can be, for example, “disinfectionmembers” configured to disinfect the portion of the fluid reservoir.

The specific configurations of the various components can also bevaried. For example, the size and specific shape of the variouscomponents can be different from the embodiments shown, while stillproviding the functions as described herein. More specifically, the sizeand shape of the various components can be specifically selected for adesired rate of bodily-fluid flow into a fluid reservoir. Similarly, thesize and/or specific shape of various components can be specificallyselected for a desired fluid reservoir. For example, portions of theembodiments described herein can be modified such that any suitablecontainer, microcontainer, microliter container, vial, microvial,microliter vial, nanovial, sample bottle, culture bottle, tube, syringe,etc. can be placed in contact with a disinfection member to sterilizeone or more interfaces associated therewith prior to a bodily-fluidbeing drawn into a volume so defined.

Where methods and/or events described above indicate certain eventsand/or procedures occurring in certain order, the ordering of certainevents and/or procedures may be modified. Additionally, certain of theevents may be performed concurrently in a parallel process whenpossible, as well as performed sequentially as described above.

1. An apparatus, comprising: a fluid reservoir having an inlet surface,the fluid reservoir configured to receive a volume of bodily-fluidtransferred from a patient; a sterilization member operably coupled tothe fluid reservoir, the sterilization member defining at least aportion of a substantially sterile environment, the sterilization memberconfigured to be transitioned between a first configuration, in whichthe sterilization member obstructs the inlet surface and maintains theinlet surface in the substantially sterile environment, and a secondconfiguration, in which the inlet surface is unobstructed; and atransfer adapter configured to be placed in fluid communication with aportion of a patient, the transfer adapter configured to move relativeto the sterilization member from a first position to a second position,a surface of the transfer adapter configured to contact thesterilization member as the transfer adapter moves to the secondposition to transition the sterilization member from the firstconfiguration to the second configuration, the fluid reservoir beingplaced in fluid communication with the transfer adapter when thetransfer adapter is in the second position.
 2. The apparatus of claim 1,further comprising: a housing defining an inner volume, the housingbeing coupled to the sterilization member such that the inner volume ofthe housing forms the substantially sterile environment when thesterilization member is in the first configuration, the fluid reservoirbeing disposed within the inner volume of the housing.
 3. The apparatusof claim 1, further comprising: a housing defining an inner volume, thehousing being coupled to the sterilization member such that the innervolume of the housing forms the substantially sterile environment whenthe sterilization member is in the first configuration, the fluidreservoir being disposed within the inner volume of the housing, thesterilization member being coupled to the housing when in the firstconfiguration, the sterilization member being at least partially removedfrom the housing when in the second configuration.
 4. The apparatus ofclaim 3, wherein the sterilization member is at least one of a sheet, afoil, a cap, a membrane, or a diaphragm removably coupled to thehousing.
 5. The apparatus of claim 1, wherein the sterilization memberincludes a disinfection agent defining at least a portion of thesubstantially sterile environment, the sterilization member is coupledto a portion of the fluid reservoir such that the disinfection agent isin contact with the inlet surface.
 6. The apparatus of claim 1, whereinthe sterilization member includes a disinfection agent defining at leasta portion of the substantially sterile environment, the sterilizationmember is coupled to a portion of the fluid reservoir such that thedisinfection agent is in contact with the inlet surface, thesterilization member defining an opening in fluid communication with thedisinfection agent, the sterilization member including a seal memberconfigured to obstruct the opening when the sterilization member is inthe first configuration, the surface of the transfer adapter configuredto contact the seal member when the transfer adapter is moved from thefirst position to the second position to place the sterilization memberin the second configuration, the opening being unobstructed by the sealmember when the sterilization member is in the second configuration. 7.The apparatus of claim 1, wherein the sterilization member is removablycoupled to a portion of the fluid reservoir, the sterilization memberand the portion of the fluid reservoir collectively defining a volumeforming at least a portion of the substantially sterile environment, theinlet surface being disposed within the volume when the sterilizationmember is in the first configuration, the surface of the transferadapter configured to decouple the sterilization member from the portionof the fluid reservoir to place the sterilization member in the secondconfiguration as the transfer adapter is placed in the second position.8. A system for parenterally-procuring bodily-fluid samples with reducedcontamination from microbes exterior to the bodily-fluid source,comprising: a sample reservoir including an inlet surface; a handleconfigured to be placed in fluid communication with a patient, thehandle having a coupler, a fluid reservoir, and an actuator, the fluidreservoir disposed within the handle and configured to receive a volumeof bodily-fluid from the patient, the actuator configured to betransitioned between a first configuration, in which the coupler isfluidically isolated from the fluid reservoir, and a secondconfiguration, in which the coupler is in fluid communication with thefluid reservoir; and an adapter configured to be coupled to the couplerof the handle, the adapter at least temporarily coupled to asterilization member and to the sample reservoir such that the inletsurface is maintained in a substantially sterile environmentcollectively defined by the adapter and the sterilization member priorto the adapter being coupled to the coupler of the handle, thesterilization member being at least partially removed from the adapterwhen the adapter is coupled to the coupler of the handle.
 9. The systemof claim 8, wherein the coupler is configured to puncture the inletsurface of the fluid reservoir when the adapter is coupled to thecoupler.
 10. The system of claim 8, wherein the coupler is configured topuncture the inlet surface of the fluid reservoir when the actuator istransitioned from the first configuration to the second configuration.11. The system of claim 8, wherein the handle defines at least one portconfigured to be coupled to a pre-sample reservoir, the actuator beingin a locked configuration prior to the pre-sample reservoir beingcoupled to the at least one port, the pre-sample reservoir configured toreceive a volume of bodily-fluid prior to the fluid reservoir disposedwithin the handle.
 12. The system of claim 8, wherein the actuator is afirst actuator, the coupler including a second actuator, the secondactuator configured to be actuated after the adapter is coupled to thecoupler to establish fluid communication between the coupler and thesample reservoir.
 13. The system of claim 8, wherein the actuator is afirst actuator, the adapter including a second actuator, the secondactuator configured to be actuated after the adapter is coupled to thecoupler to establish fluid communication between the coupler and thesample reservoir.
 14. The system of claim 8, wherein the adapter is afirst adapter, the system further comprising: a second adapterconfigured to be coupled to the coupler of the handle, the secondadapter including a lumen-defining device configured to be placed influid communication with the patient, the actuator configured to betransitioned from the first configuration to the second configuration toestablish fluid communication between the lumen-defining device and thefluid reservoir when the second adapter is coupled to the coupler of thehandle.
 15. The system of claim 14, wherein the second adapter iscoupled to a pre-sample reservoir configured to receive a first volumeof bodily-fluid, the pre-sample reservoir configured to be decoupledfrom the second adapter prior to the second adapter being coupled to thecoupler such that the first volume of bodily-fluid is sequestered in thepre-sample reservoir.
 16. The system of claim 15, wherein the pre-samplereservoir prevents the second adapter from being coupled to the couplerof the handle when the pre-sample reservoir is coupled to the secondadapter.
 17. -25 (anceled)